Yorkshire Specialist Register of Cancer in Children and Young People

In term In term in the September 2026 edition: the latest version runs to 28 February 2027.

Reference: DARS-NIC-11809-H1Y3W
Current version: v7.2
Term of current version: 22 May 2025 to 28 February 2027
Start date: Before 1 September 2019
Data controller: Sole Data Controller
Commercial purposes: No
Sublicensing: No
Files released to date: 460

Why the data was released

Objective for processing

The University of Leeds requires access to NHS England data for the purpose of the following research project: Yorkshire Specialist Register of Cancer in Children and Young People (YSRCCYP). Cancer registration data from the YSRCCYP is used to carry out a programme of epidemiological and applied health research as set out in the Yorkshire Register protocol.

The YSRCCYP is a specialist register focusing on tumour registrations diagnosed in the Yorkshire and Humber region since 1974 for patients aged 0-14 years and 1990 for those aged 0-39 years. The YSRCCYP research team, within the University of Leeds, is notified of patients eligible for inclusion in the YSRCCYP either directly by the patient’s treatment centre or via electronic reports from the NCRAS, the latter covered by this Data Sharing Agreement (DSA).

Childhood cancer registration details for those aged 0-15 years are primarily provided via the two Principal Treatment Centres, at Leeds Children’s Hospital and Sheffield Children’s Hospital, with a secondary source being the NCRAS. For 16-39 year olds, these are primarily provided by the National Cancer Registration and Analysis Service (NCRAS), with secondary sources being Teenage and Young Adult Principal Treatment Centres in Leeds and Sheffield. The NCRAS is also the primary source of information for these children and young people if diagnosed with any subsequent tumours or relapses at any age and living inside or outside the Yorkshire region at the time.

The NHS England dataset also provides data on death registrations for any existing tumour registration since 1974 on an annual basis as part of this annual data extract.

Below is a summary of the YSRCCYP research team’s research plans which include the following objectives:

1) To describe the total burden of physical and mental health hospitalisation among the Yorkshire cancer population aged 0-39 years, to identify clinical and sociodemographic factors which influence the likelihood of hospitalisation and to investigate how hospitalisation rates have changed since 1997.

2) To understand patient care pathways through the NHS before, during and after cancer diagnosis. This includes assessment of time to diagnosis for children and young adults diagnosed with cancer under the age of 40 years to identify where improvements can be made to minimise delays in diagnosis leading to better prognosis and less stress and anxiety on patients and their families.

3) To calculate the risks and costs to the NHS of adverse physical and mental health events requiring hospital admission for survivors of cancer in this age group so that clinicians can provide appropriate follow-up care.

4) To identify the risks of cardio-metabolic disease in long-term childhood and young adult cancer survivors. Specific risk markers for cardiovascular disease plus metabolic factors associated with metabolic syndrome and type II diabetes will be collected. The study team will also obtain a range of additional biomarkers of cardiovascular risk. This data will facilitate a programme of research assessing the prevalence of endocrine complications and cardiometabolic late effects in long-term childhood and young adult cancer survivors.

5)i)To identify the impact of cancer treatment on kidney toxicity and mental health, specifically anxiety and depression. In this project researchers aim to enhance the treatment data held in the register through linkage with the national Systemic Anti-Cancer Therapy (SACT) dataset and hospital electronic prescribing systems such as ChemoCare*. It is hoped this will enable researchers to compare the chemotherapy doses and intensities given to patients with the same tumour types and see if this has any effect on outcomes including survival and relapse. Researchers may also be able to look at the toxicities experienced by patients by reviewing routine measurements and blood tests collected prior to chemotherapy. From this, researchers may be able to see if any dose modifications were made as a result and again look at whether this had any effect on patient outcome. By comparing patients treated at different hospitals. researchers may, for some tumour types, be able to see whether, and if so how, practices differ between Principal Treatment Centres and peripheral hospitals.

ii) An extension of this project is to look in more detail at the impact of cancer treatments on kidney toxicity. Routine bloods tests and measurements held will be enhanced by the collection of urinary analyses, microbiology results, radioisotope measurements and the prescription of any anti-hypertensive medications. These additional fields will give researchers a greater insight into the kidney toxicity caused.

*Please note, the data added to the YSRCCYP from data sources such as ChemoCare, will never be linked to NHS England at record level. Only aggregated outputs with small numbers suppressed will be compared.

6) To provide contextual information on existing physical and mental health morbidity when evaluating educational and employment outcomes. As part of the ongoing research the study team collect additional information for patients on the register attending the long-term follow-up clinics at Leeds Teaching Hospitals Trust. Patients attending these clinics complete a holistic needs assessment which includes the completion of the distress thermometer and a problems check list. These data items are used as a measure of psychological health to assess the prevalence of distress in long term cancer survivors and the associations between patient characteristics and levels of distress.

To address aims 1 and 4, the YSRCCYP research team will utilise HES and Mental Health data to investigate long term risks of all major morbidity (e.g. cardio-metabolic, respiratory, mental health illness) in the cohort and identify sociodemographic and clinical factors which may affect these risks. The YSRCCYP research team also wish to determine the relative excess risk of these conditions within the cancer cohort compared to the general background population and, in order to make this comparison, requires a separate pseudonymised extract of HES data containing all episodes for YSRCCYP members in the Yorkshire and Humber SHA area only under the age of 65 at admission (the oldest person currently registered in the database). This separate extract is covered under Agreement DARS-NIC-155843-0MQMK.

To address aims 2 and 3 evaluating clinical care pathways and time to diagnosis also require data of all admissions prior to cancer diagnosis. The late health effects for childhood and young adult cancer survivors may occur any time after treatment ends and the risk of late effects increases as the cohort ages. In order to fully evaluate the total burden of adverse health events in these survivors’, data are required for as long a time period as possible. This may also include any hospital admissions prior to the patient’s cancer diagnosis to identify any underlying health conditions. The YSRCCYP research team is also notified about any subsequent malignant neoplasms from the National Cancer Registration and Analysis Service prospectively following the original cancer diagnosis and therefore need to retain all historical HES and mental health data in order to scrutinise any such individual’s history of hospital admissions and understand potential reasons for those who experience multiple tumour diagnoses.

Rates of admission within the cancer survivors have previously been compared to pseudonymised hospital admission rates to work out standardised hospitalization admission ratios and assess whether these differed according to cancer diagnosis, treatment, ethnic group, gender, age group, period of diagnosis and socioeconomic status, using statistical models adjusting for patient case-mix while also incorporating the general background hospital admission rates. (Althumairi, University of Leeds, 2017). To address aim 3 this process will be repeated using the latest data with a focus on specific disease groups, including cardio-metabolic, kidney disease, anxiety and depression, as well as total physical and mental health morbidity data, using a similar methodology as the YSRCCYP research team’s previously published work on cardiovascular disease, respiratory morbidity and cumulative burden.

Aim 4 will examine the lifelong risk for the development of endocrine complications or adverse cardio-metabolic health outcomes attributable to the cancer and/or treatment with a specific focus on these risks in relation to ethnic group and socio-economic status.

Aim 5 will enable the YSRCCYP research team to estimate the risk of kidney disease, anxiety and depression among the Yorkshire survivorship cohort, whether this risk has changed over time and the points at which it may appear in the survivor's cancer treatment. The key clinical factors which influence the risk of kidney disease, anxiety and depression will also be identified.

A current research focus is on hospital burden around the time of diagnosis and treatment and monitoring long term risks of hospitalisation associated with cancer treatment. One specific processing activity will relate to describing the risks and prevalence of mental health illness within the cancer cohort compared to the general population. Using data from March 2020 onwards, the study team will examine any changes in the long-term health risks by identifying those individuals in the cohort who tested positive for Sars-Cov-2 infection.

Aim 6 will provide important clinical information on existing health problems, identified from HES data, when describing educational attainment and employment trajectories for the young people diagnosed with cancer in Yorkshire. Specifically, those with existing health problems will be identified and this information will be taken into account as a potential confounding factor when examining the risks of poor educational or employment outcomes among the entire survivor cohort. Furthermore, the YSRCCYP research team will be able to determine whether the risks of poor educational or employment outcomes are exacerbated for those with pre-existing illness.

As a result of the Covid-19 pandemic, a patient’s Covid-19 status and related data (such as date positive status was confirmed and shielding status) are also collected. This enables an analysis of the impact of Covid-19 on cancer treatments for children and young people (such as delays in treatment or non-start of treatments) and long-term health and social outcomes. Also resulting from the changes to working practices in response to the Covid-19 pandemic, data collection is completed remotely where possible. Approval has been obtained from NHS Trusts for remote access to digitalised patient notes.

This type of epidemiological and health services research has the potential to benefit future patients by identifying risk factors which can be used by health professionals to identify those at greatest risk of mental health illness so that interventions and appropriate support can be implemented. It may also reveal important environmental risk factors, examine changes in incidence rates which may help to identify possible causes and understand survival patterns according to ethnic group and socio-economic status in order to ensure that there are no inequalities in outcomes or access to specialist cancer care for certain sub-populations. The research will also have the potential to determine the impact of the COVID-19 pandemic on long-term health outcomes since March 2020.

This agreement covers the following NHS England (NDRS) datasets to be supplied on an annual basis. (Data previously disseminated under DSA reference DARS-NIC-656761-R6H7W):

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Outpatients

• Emergency Care Data Set (ECDS)

• Mental Health

• Cancer Registration

• NDRS Cancer Registration

• NDRS National Radiotherapy Dataset (RTDS)

• NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

The level of data will be identifiable - necessary to enable linkage of the data with data collected from other sources within the YSRCCYP (local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs). In order to evaluate long-term health and social outcomes. Identifiable data items are essential so that the YSRCCYP data manager can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information.

The data will be minimised as follows:

• Limited to data for the YSRCCYP cohort identified by the University of Leeds, i.e. patients aged 0-14 years diagnosed with cancer in Yorkshire & the Humber between 1974-1989 and patients aged 0-39 years since 1990.

• All valid ICD10 codes for cause of death.

• ICD10 codes C00 – C97, D00-D05, D07-D48 for second primary tumours.

The University of Leeds is the research sponsor and the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it relates to cancer registration, specifically to examine long-term health and social outcomes for children and young people diagnosed in Yorkshire. Findings will provide information on those groups whose outcomes are worse than their peers and this will be used to inform future decisions over patients’ treatment and care.

The funding is provided by the Candlelighters Trust, Leeds. The funding is specifically for the YSRCCYP cohort described. Funding is in place until 31/5/2027. The funder will have no ability to suppress or otherwise limit the publication of findings.

The YSRCCYP database is currently stored on the University of Leeds's cloud platform called LASER which is provided by Microsoft Limited. It is anticipated The University of Leeds will migrate the data to AIMES Management Services in 2024, to which an amendment to this DSA to update the processor as required will be submitted.

Microsoft Limited provides IT hosting services to the University of Leeds and will store the data as contracted by the University of Leeds. Microsoft Limited also provides IT back up services to the University of Leeds and will store copies of the data as contracted by the University of Leeds.

Data will be accessed by:

• Undergraduate, Masters or PhD students affiliated with the University of Leeds. Any student working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to the University of Leeds’ policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of a substantive employee of the University of Leeds. The University of Leeds would be responsible and liable for any work carried out by students. These students would only work on the data for the purposes described in this Agreement. Any education benefit gained from carrying out this work would be an associated benefit and would not be the primary reason for the research being conducted nor the primary reason for their involvement.

• An individual from Hull University Teaching Hospitals NHS Trust will be working on specific data extracts for their own clinical academic training, holding an honorary contract (visiting title) with the University of Leeds. The honorary contract holder is a junior doctor who requires research experience as part of their clinical academic training in order for them to continue with their career. They will be performing the statistical analysis for the study. An appropriate contract between the individual and the University of Leeds is in place.

Any individual working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to the University of Leeds’ policies on data protection and confidentiality. Any individuals accessing the data will do so under the supervision of a substantive employee of the University of Leeds. The University of Leeds would be responsible and liable for any work carried out by these individuals. These individuals would only work on the data for the purposes described in this Agreement. Any education or clinical academic benefit gained from carrying out this work would be an associated benefit and would not be the primary reason for the research being conducted nor the primary reason for their involvement.

The YSRCCYP Scientific Advisory Group provides advice on key strategic objectives, monitors progress on these objectives, monitors the quality of the scientific work of the project and provides guidance on complex issues when needed, e.g. the release of sensitive findings. Details of current members can be found on the YSRCCYP website: https://ysrccyp.org.uk/about/scientific-advisory-group/.

The National Institute for Health and Care Research (NIHR) Clinical Research Fellow within the YSRCCYP team, has led on the development of two national Public and Patient Information and Engagement workshops in February 2022 and April 2022 in conjunction with DATA-CAN exploring young people’s views on the use of health data for research purposes. This included discussion around cancer registration and data linkage with education and employment datasets. There was strong support from the group in favour of these ongoing research activities and these findings are being written-up for publication later this year. The workshops also helped to inform the research strategy because the late effects of cancer were also one of the young people's research priorities. These young people are also supporting University of Leeds in individual research projects and grant applications.

The NIHR Clinical Research Fellow and the Register Statistician, have also represented the work of the YSRCCYP and Candlelighters’ Trust at the ‘Be Curious’ public engagement event for children and their families held at the University of Leeds in May 2023. This was a huge success with numerous families asking questions about the research and expressing interest about being involved in future Patient and Public Involvement and Engagement (PPIE) events related to the YSRCCYP. There was significant diversity of families attending the event, for example children attended from the Bradford East family hub along with families where English was their second language. This provided University of Leeds with the ability to engage with the harder to reach populations.

Patients are made aware of all data flows through leaflets distributed at the main Principal Treatment Centres, posters on hospital wards, webinars with the local charity funders (Candlelighters Trust) and the YSRCCYP register website and fair processing statement which is published on the University of Leeds website. University of Leeds have also engaged with groups such as the GenerationR Young People’s Advisory Group at Leeds General Infirmary where the research from the YSRCYP is disseminated to young people in accessible forms.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Processing activities

For NDRS linkage, NHS England will provide the relevant records already flagged from the NDRS dataset to the University of Leeds in terms of latest vital status i.e. death registration data, relapse, secondary malignant neoplasms and any subsequent treatment received. NHS England will also provide relevant records on all new cancer registrations aged 0-39 years at diagnosis resident in Yorkshire as well as the same details listed in the previous sentence. NHS England will flow back identifiable data such as NHS number, full name, date of birth, sex and postcode so that University of Leeds can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information. These identifiers are stored and then used to enable data linkage with information collected from other sources such as local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs) data as described in the YSRCCYP data flow diagram, as part of the epidemiological research programme to monitor long-term health and social outcomes.

Data will be stored on the ARO secure cloud platform and Leeds Analytic Secure Environment for Research (LASER). LASER is a custom Virtual Research Environment (VRE) based on Microsoft Azure technologies operated by the University of Leeds. LASER uses the Microsoft Azure UK South data centre.

https://lida-data-analytics-team.github.io/laserdocs/docs/laser_info/laser.html.

Backups are handled by Microsoft Azure Recovery Services (MARS) agent and uses a Backup Service Vault, connected to Azure storage services based in the UK and ARO secure cloud platform.

As per the University of Leeds policy data is classified using a data risk tiering system based on the perceived impact of disclosure. All data from projects like the YSRCCYP generally falls within tier 3 or 4. Identifiable data is generally classified as tier 4, i.e. significant impact to University of Leeds, partners or individuals with potential for substantial legal, financial or reputational penalties. Pseudonymised / De-identified data is generally classified as tier 3, i.e. high impact to University of Leeds, partners or data subjects with potential for contractual, commercial, legal, financial or reputational penalties.

Identifiable data is held within a separate VRE that can only be accessed from within a designated safe room onsite at the University of Leeds. Pseudonymised data is held in a separate VRE that can be accessed by authorised personnel remotely. Data ingress and egress of all data is controlled by the LASER Data Analytics Team (DAT). https://lida-data-analytics-team.github.io/laserdocs/docs/lida_services/dat.html. Research staff do not have the ability to copy any dataset to an external device.

The identifiable data will not leave England at any time and the data will not be transferred to any other location.

The Data will be accessed by authorised personnel via remote access. The Data will remain on ARO secure cloud platform and servers at Leeds Analytic Secure Environment for Research (LASER), at all times.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy.

Access is restricted to individuals within the YSRCCYP research team at the University of Leeds who have authorisation from the Principal Investigator (PI). All such individuals are substantive employees of the University of Leeds, Undergraduate, Masters or PhD students affiliated with the University of Leeds. An individual from Hull University Teaching Hospitals NHS Trust will be working on specific data extracts for their own clinical academic training, holding an honorary contract (visiting title) with the University of Leeds.

Access to each pseudonymised / de-identified dataset held will be restricted to designated YSRCCYP affiliated researchers who have been authorised by either the PI or designated officer. Access to patient identifiable data is restricted to employees of the University of Leeds who are YSRCCYP affiliated. These researchers will have specifically been granted access by the PI dependent on their job role. YSRCCYP researchers can potentially have prepared identifiable datasets in locations within the VRE with bespoke access restrictions to minimise the individuals with access to the full identifiable data held. Individuals with an honorary contract / visiting title act as an agent of the University of Leeds at all times under supervision of University employees.

Access to the core identifiable dataset will be restricted to a minimum number of individuals within the YSRCCYP research team. Research data extracts will be approved by data managers and research statisticians within the team. A data asset log will be maintained documenting the source / code used to produce use, storage location and approved users. All requests are approved by the Principal Investigator via email, which acts as an additional audit trail.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Microsoft Limited provide Cloud Services for the University of Leeds Cloud Services for the University of Leeds and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.

ARO provide Cloud Services for the University of Leeds and are therefore listed as a data processor. They host the YSRCCYP database’s secure cloud infrastructure. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.

The data will be linked at person record level with datasets obtained from NHS England (NDRS & HES), Leeds Teaching Hospitals NHS Trust (PPM; PROMs), Department for Education (National Pupil Database), Department for Work and Pensions, and HMRC.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Data managers and researchers from the YSRCCYP research team at the University of Leeds will process the data for the purposes described above.

Researchers from the YSRCCYP research team at the University of Leeds will use the relevant subset of data to analyse incidence and survival trends including long-term health and outcomes, as described above.

Expected output

The expected outputs of the processing will be:

• A report of findings to the Candlelighters Trust on an annual basis.

• Submissions to peer reviewed journals, expected to be at least two submissions per year.

• Presentations to the Candlelighters Trust as well as local and regional clinical and research seminars.

• Presentations at Cancer Research UK, National Cancer Registration and Analysis Service Cancer Outcomes annual meeting, Teenage Cancer Trust and the International Society of Paediatric Oncology annual conferences.

• Publication of infographics on the YSRCCYP’s website: www.ysrccyp.org.uk.

• A database to be utilised as a resource for health research.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals (e.g. BMC Cancer)

• Workshops involving clinicians and researchers working in the childhood and young adult cancer field, e.g. NCRI TYA and Germ Cell tumour Clinical Services Group.

• Webinars open to academic and clinical researchers in the UK.

• Social media

• Posters displayed at Cancer Research UK, CCLG, TYAC and SIOP conferences.

• Patient Information leaflets available at the YSRCCYP website: www.ysrccyp.org.uk.

• Press/media engagement

• Public promotion of the research, e.g. Be Curious event at the University of Leeds.

The target dates for production and dissemination of the outputs are:

• Journals: 2 per year, e.g. germ cell tumour dose intensity paper to be submitted by July 2023, early mortality paper to be submitted by Dec 2024, cardio-metabolic paper to be submitted by Dec 2024. Analyses describing educational outcomes will be submitted for publication by Summer 2025 to the International Journal of Cancer (or similar). Work will be submitted to the European Journal of Cancer (or similar) in relation to specific cardio-metabolic disease by Summer 2025. Risks of kidney toxicity will be submitted for publication by Summer 2024 in the British Journal of Cancer (or similar). Risks of anxiety, depression and overall mental health disorders will be submitted for publication by Winter 2025 in the International Journal of Cancer (or similar).

• Workshops involving clinicians and researchers working in the childhood and young adult cancer field, e.g. NCRI TYA and Germ Cell tumour Clinical Services Group: 3 per year.

• Webinars open to academic and clinical researchers in the UK: 2 per year.

• Social media: coinciding with each journal publication, 2 per year.

• Posters displayed at Cancer Research UK, CCLG, TYAC and SIOP conferences: 3 per year.

• Patient Information leaflets available at the YSRCCYP website: www.ysrccyp.org.uk: ongoing and updated regularly.

• Press/media engagement: coinciding with each journal publication, 2 per year.

• Public promotion of the research, e.g. Be Curious event at the University of Leeds: twice per year.

Details of risk stratification models and the methodology to derive these for individual patients will be disseminated by the research team to every clinician involved in the care of children and young people (CYP) in August 2025. This will be supported by the Yorkshire & Humber CYP cancer network that holds details of all practicing NHS CYP cancer teams and clinicians in the region.

The linked NHS England data alongside the background hospitalisation rates will be used to derive key information which will be provided by the YSRCCYP research team to clinicians involved in the long-term care of young people identifying each individual’s risk stratification group (defined as being at ‘low’, ‘medium’, or ‘high’ risk of future complications or health effects, based upon their previous hospital activity patterns, treatment mortality, dose, cancer type and stage). The risk stratification model will be devised by the YSRCCYP research team and disseminated to clinicians in the Yorkshire and Humber region via the Y&H Children’s and Young People’s Cancer Network (August 2025). Only those clinicians involved in the direct care of individuals with cancer will be provided with details of the risk stratification model. Health care commissioners will be provided with aggregated cancer intelligence data on the number of survivors currently being seen at each NHS Trust according to risk stratification group, so future services can be planned effectively (Summer 2025).

Summary reports of the work and research undertaken will be compiled and also made available on the Yorkshire Register University of Leeds website (www.ysrccyp.org.uk), according to the timelines listed earlier in the document.

All outputs will be aggregated with small number suppression in line with the HES Analysis Guide.

Data will be held for as long as the research project is funded to undertake this piece of epidemiological and applied health research. Current funding expires on 31st May 2027. Subject to securing ongoing funding, the data would be retained until December 2027 to allow sufficient time for completion of analyses, submission and final publication of papers.

Expected measurable benefits

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to childhood and young adult cancer.

The use of the data could:

• help the system to better understand the health and care needs of the childhood and young adult cancer population in Yorkshire.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of regional trends in health and social care needs.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes for children and young people with cancer.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

Potential benefits could comprise:

• An ability to evaluate changes in risk of death for children and young people diagnosed with cancer in Yorkshire and determine whether differences exist by ethnic group, deprivation and stage at diagnosis.

• Identify those groups of survivors who are most likely to experience the poorest health and social outcomes so that appropriate interventions and improvements in care quality can be devised.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to childhood and young adult cancer patients and survivors in Yorkshire.

University of Leeds will use multiple channels to disseminate key findings. These will include:

• The Candlelighters Trust Families Group

• The CCLG’s Late Effects Group

• The NCRI CTYA and Germ Cell Tumour Clinical Services Group

• PPIE events such as those organised by the Candlelighters Trust and University of Leeds, e.g. Be Curious.

• International scientific meetings, e.g. SIOP, Global AYA Cancer Congress.

• The YSRCCYP website: www.ysrccyp.org.uk.

The Candlelighters Trust, as the main funder of the YSRCCYP research programme, have been an important source of support in making sure that the outputs are provided in clear formats and at appropriate public meetings

Benefits reported so far

Update provided on 21/12/2023

Multiple peer-reviewed publications describing the epidemiology and long-term outcomes for children and young people diagnosed with cancer in Yorkshire.

A full list can be found here:

https://ysrccyp.org.uk/research/publications/

Some specific examples:

1) The data collected as part of the YSRCCYP has allowed researchers to better understand the burden on NHS services of late cardiovascular and respiratory morbidity as well as second cancers survivors and quantifies the long-term risk of such morbidity for survivors and healthcare professionals looking after them. It has enabled childhood and young adult cancer survivors and their families to understand more about their own risk of developing these longer-term health problems according to their original diagnosis and treatment, and at what age they are most likely to appear. In effect, young cancer patients have been able to take ownership of their own survivorship.

2) The YSRCCYP database has facilitated the production of an up-to-date summary of the latest literature relating to late consequences of cancer treatment on reproductive health, describing the impact on both fertility and pregnancy. This has provided awareness and information to cancer survivors from Yorkshire about reproductive outcomes to enable them to plan fertility storage at the earliest opportunity and maximise the chances of having

their own offspring. Additionally, the identification of a sparsity of evidence on outcomes of ovarian and testicular tissue resulted in establishment of a multi-centre initiative to establish a population based register of individuals with stored ovarian and testicular tissue in the United Kingdom (UK).

3) It has allowed researchers to quantify respiratory morbidities, treatment-related risks and their relationship to subsequent morbidity and mortality among long-term survivors of childhood and young adult cancer in Yorkshire. This information has been made available to the clinical community in Yorkshire in the form of research papers, regular webinars and infographics so that those health professionals looking after young cancer survivors are able

to inform them of their risks of morbidity depending on their original cancer diagnosis and treatment, and at what age these are likely to be develop.

4) It has allowed researchers to quantify the prevalence and spectrum of mental health problems found in adult survivors of childhood cancer, based on a systematic review of the current evidence. Problems ranged from depression, anxiety, behavioural problems and drug misuse. Factors increasing the likelihood of mental health problems included treatment with high-dose anthracyclines, cranial irradiation, diagnoses of sarcoma or central nervous system tumours and ongoing physical ill health. The review recommended further work to identify

childhood cancer patients who are at risk of developing late mental health morbidity.

5)The first comprehensive analysis of hospital mental health episodes following CTYA cancer treatment (Friend, PhD thesis, 2020), preceded by a systematic review of the current evidence (Friend et al, Int J Cancer 2018).

6)The YSRCCYP research team found that the National Cancer Survivorship Initiative paediatric late-effects risk stratification system can be effectively and safely applied to cancer patients aged 18-39, independent of ethnicity or socioeconomic position. This evidence has supported clinical services in Yorkshire and further afield across the UK to safely adopt risk-stratified care pathways for the long term follow up of individuals living with and beyond

cancer.

Datasets on the current version

Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets approved under DARS-NIC-11809-H1Y3W-v7.2
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Cancer Registration Data	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Emergency Care Data Set (ECDS)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
HES-ID to MPS-ID HES Accident and Emergency	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
HES-ID to MPS-ID HES Admitted Patient Care	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
HES-ID to MPS-ID HES Outpatients	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Accident and Emergency (HES A and E)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Admitted Patient Care (HES APC)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Outpatients (HES OP)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Mental Health and Learning Disabilities Data Set (MHLDDS)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Mental Health Minimum Data Set (MHMDS)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Mental Health Services Data Set (MHSDS)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
NDRS Cancer Registrations	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
NDRS National Radiotherapy Dataset (RTDS)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
NDRS Systemic Anti-Cancer Therapy Dataset (SACT)	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

Patient opt-outs were applied to 408 of the 460 files released under this agreement, across every version. About opt-outs

Files released against version 7.2 of this agreement, summarised by dataset.

Files released under DARS-NIC-11809-H1Y3W-v7.2
Dataset	Files	First released	Last released	Opt-outs applied
NDRS Cancer Registrations	8	May 2026	August 2026	Yes
NDRS National Radiotherapy Dataset (RTDS)	4	May 2026	August 2026	Yes
NDRS Systemic Anti-Cancer Therapy Dataset (SACT)	4	May 2026	August 2026	Yes

Version history

The register lists each renewal of this agreement as a separate row. This site has 6 versions — earlier versions existed before this site's records begin.

DARS-NIC-11809-H1Y3W-v7.2 22 May 2025 to 28 February 2027

Title: Yorkshire Specialist Register of Cancer in Children and Young People
Commercial: No
Sublicensing: No
Datasets: 14
Files released: 16

Datasets: Cancer Registration Data; Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); NDRS Cancer Registrations; NDRS National Radiotherapy Dataset (RTDS); NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

What changed from DARS-NIC-11809-H1Y3W-v6.2

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-11809-H1Y3W-v6.2
Field	Was	Became
Start date	~~2024-03-01~~	2025-05-22
Cancer Registration Data: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Emergency Care Data Set (ECDS): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
HES-ID to MPS-ID HES Accident and Emergency: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
HES-ID to MPS-ID HES Admitted Patient Care: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
HES-ID to MPS-ID HES Outpatients: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Outpatients (HES OP): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Mental Health Minimum Data Set (MHMDS): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Mental Health Services Data Set (MHSDS): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Mental Health and Learning Disabilities Data Set (MHLDDS): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets: ~~− Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set~~

Objective for processing

[3 paragraphs unchanged] Childhood cancer registration details for those aged 0-15 years are primarily provided [19 words unchanged] the NCRAS. For 16-39 year olds, these are primarily provided by the ~~NCRAS,~~ National Cancer Registration and Analysis Service (NCRAS), with secondary sources being Teenage and Young Adult Principal Treatment Centres in [28 words unchanged] age and living inside or outside the Yorkshire region at the time. [19 paragraphs unchanged] ~~In order to meet the above objectives, The University of Leeds request an update to the following NHS England datasets to be supplied at year 3 within this agreement.~~ This agreement covers the following NHS England (NDRS) datasets to be supplied on an annual basis. (Data previously disseminated under DSA reference DARS-NIC-656761-R6H7W): ~~-Mental Health Services Data Set (MHSDS)~~ The following NHS England Data will be accessed: ~~-Mental Health and Learning Disabilities Data Set (MHLDDS)~~ • Hospital Episode Statistics ~~-Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set~~ o Admitted Patient Care ~~-Hospital Episode Statistics Admitted Patient Care (HES APC)~~ o Accident & Emergency ~~-Hospital Episode Statistics Outpatients (HES OP)~~ o Outpatients ~~-Emergency~~ • Emergency Care Data Set (ECDS) ~~-Hospital Episode Statistics Accident and Emergency (HES A and E)~~ • Mental Health ~~The University of Leeds request an update to the following NHS England (NDRS) datasets to be supplied on an annual basis. (Data previously disseminated under DARS-NIC-656761):~~ • Cancer Registration ~~-Civil Registration Mortality – necessary to calculate survival estimates to examine early mortality and long-term trends in survival for the YSRCCYP cohort.~~ • NDRS Cancer Registration ~~-NDRS Cancer Registration – necessary to ensure that the YSRCCYP has complete case ascertainment for all patients aged under 40 years in Yorkshire, as well as any subsequent tumours or relapses.~~ • NDRS National Radiotherapy Dataset (RTDS) ~~-NDRS National Radiotherapy Dataset (RTDS)~~ • NDRS Systemic Anti-Cancer Therapy Dataset (SACT) ~~-NDRS Systemic Anti-Cancer Therapy Dataset (SACT)~~ The level of data will be identifiable - necessary to enable linkage of the data with data collected from other sources within the YSRCCYP (local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs). In order to evaluate long-term health and social outcomes. Identifiable data items are essential so that the YSRCCYP data manager can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information. The level of data will be identifiable necessary to enable linkage of the data with data collected from other sources within the YSRCCYP (local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs). In order to evaluate long-term health and social outcomes. Identifiable data items are essential so that the YSRCCYP data manager can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information. [18 paragraphs unchanged] The ~~NIHR~~ National Institute for Health and Care Research (NIHR) Clinical Research Fellow within the YSRCCYP team, has led on the development [100 words unchanged] also supporting University of Leeds in individual research projects and grant applications. The NIHR Clinical Research Fellow and the Register Statistician, have also represented [38 words unchanged] questions about the research and expressing interest about being involved in future ~~PPIE~~ Patient and Public Involvement and Engagement (PPIE) events related to the YSRCCYP. There was significant diversity of families attending [25 words unchanged] Leeds with the ability to engage with the harder to reach populations. [1 paragraph unchanged] This contract is reliant on the Data Recipient maintaining the continued support for use of confidential patient information without consent, according to regulations made under section 251 of the NHS Act 2006 (20CAG0133). The study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. [1 paragraph unchanged]

Processing activities

[1 paragraph unchanged] For HES linkage, the registration data will flow from University of Leeds back to NHS England and will contain directly identifying data items including NHS Number, Date of Birth, Postcode, and Gender which are required to link the data at record level with data already held by the NDRS. NHS England will then flow back the linked HES data with the YSRCCYP tumour identifier number to University of Leeds. Data will be stored on the ARO secure cloud platform and Leeds Analytic Secure Environment for Research (LASER). LASER is a custom Virtual Research Environment (VRE) based on Microsoft Azure technologies operated by the University of Leeds. LASER uses the Microsoft Azure UK South data centre. Data will be stored on Leeds Analytic Secure Environment for Research (LASER), a custom Virtual Research Environment (VRE) based on Microsoft Azure technologies operated by the University of Leeds. LASER uses the Microsoft Azure UK South data centre. [1 paragraph unchanged] Backups are handled by Microsoft Azure Recovery Services (MARS) agent and uses a Backup Service Vault, connected to Azure storage services based in the ~~UK.~~ UK and ARO secure cloud platform. [3 paragraphs unchanged] The Data will be accessed by authorised personnel via remote access. The Data will remain on ~~the~~ ARO secure cloud platform and servers at Leeds Analytic Secure Environment for Research (LASER), at all times. [12 paragraphs unchanged] Microsoft Limited provide Cloud Services for the University of Leeds Cloud Services for the University of Leeds and are therefore listed as [31 words unchanged] agreement. This includes granting of access to the database[s] containing the data. ARO provide Cloud Services for the University of Leeds and are therefore listed as a data processor. They host the YSRCCYP database’s secure cloud infrastructure. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. [4 paragraphs unchanged]

Expected output

[27 paragraphs unchanged] The linked NHS ~~Digital~~ England data alongside the background hospitalisation rates will be used to derive key [135 words unchanged] risk stratification group, so future services can be planned effectively (Summer 2025). [3 paragraphs unchanged]

Benefits reported

Update as provided on ~~the annual confirmation report submitted~~ 21/12/2023 [14 paragraphs unchanged]

Unchanged: Expected measurable benefits.

DARS-NIC-11809-H1Y3W-v6.2 1 March 2024 to 28 February 2027

Title: Yorkshire Specialist Register of Cancer in Children and Young People
Commercial: No
Sublicensing: No
Datasets: 15
Files released: 330

Datasets: Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Cancer Registration Data; Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); NDRS Cancer Registrations; NDRS National Radiotherapy Dataset (RTDS); NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

What changed from DARS-NIC-11809-H1Y3W-v5.14

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-11809-H1Y3W-v5.14
Field	Was	Became
Start date	~~2022-10-20~~	2024-03-01
End date	~~2024-01-30~~	2027-02-28

Datasets: + Cancer Registration Data; + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients; + NDRS Cancer Registrations; + NDRS National Radiotherapy Dataset (RTDS); + NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objective for processing

The University of Leeds ~~require record level Hospital Episode Statistics (HES) and Mental Health~~ requires access to NHS England data for ~~a specific cohort for~~ the ~~period from 1996/97 to 2021/22 (or latest available data). The University~~ purpose of ~~Leeds already holds identifiable Hospital Episode Statistics (HES) data and Mental Health data for this cohort which will be used, alongside data collected in~~ the following research project: Yorkshire Specialist Register of Cancer in Children and Young People ~~(YSRCCYP),~~ (YSRCCYP). Cancer registration data from the YSRCCYP is used to ~~continue its epidemiology~~ carry out a programme of epidemiological and applied health ~~services~~ research ~~programme.~~ as set out in the Yorkshire Register protocol. The YSRCCYP was originally set up in collaboration with local clinicians to [6 words unchanged] YSRCCYP database and research programme has been managed by the University of ~~Leeds’~~ Leeds' Division of Epidemiology & and Biostatistics. The University of Leeds is the Sole Data Controller for the YSRCCYP with sole responsibility for determining the purposes for which and the manner in which any personal data are processed. The work is currently funded solely by the Candlelighters Trust (https://www.candlelighters.org.uk/). The Candlelighters Trust do not determine how data is collated or processed for the study and will only access data that is aggregated with small numbers suppressed. The YSRCCYP is a regional population based register containing detailed, record-level demographic and clinical information on children and young adults aged 0-29 years diagnosed with cancer and benign central nervous system tumours since 1974. The YSRCCYP covers the Yorkshire and Humber Strategic Health Authority (SHA) which has a total population of 5 million people. The purpose of the YSRCCYP is to facilitate population-based epidemiological and health services research. The YSRCCYP is a specialist register focusing on tumour registrations diagnosed in the Yorkshire and Humber region since 1974 for patients aged 0-14 years and 1990 for those aged 0-39 years. The YSRCCYP research team, within the University of Leeds, is notified of patients eligible for inclusion in the YSRCCYP either directly by the patient’s treatment centre or via electronic reports from the NCRAS, the latter covered by this Data Sharing Agreement (DSA). Historically, cancer registration records have been identified primarily through hospital records involving manual abstraction of information from hospital notes. In recent years, the data controller has established a secure, electronic feed of information from local patient management and pathology systems (including the Patient Pathway Management (PPM) within NHS Trusts across Yorkshire), the National Cancer Registration and Analysis Service (NCRAS) , as well as primary care datasets, in order to improve the efficiency of the Yorkshire Register data collection. This flow of data is covered under section 251 approval from the HRA CAG to address the common law duty confidence. Childhood cancer registration details for those aged 0-15 years are primarily provided via the two Principal Treatment Centres, at Leeds Children’s Hospital and Sheffield Children’s Hospital, with a secondary source being the NCRAS. For 16-39 year olds, these are primarily provided by the NCRAS, with secondary sources being Teenage and Young Adult Principal Treatment Centres in Leeds and Sheffield. The NCRAS is also the primary source of information for these children and young people if diagnosed with any subsequent tumours or relapses at any age and living inside or outside the Yorkshire region at the time. From October 2021 NCRAS became part of the National Disease Registration Service (NDRS) service managed by NHS Digital. Data continues to flow to University of Leeds from the NDRS service, however this a separate flow of data to the data disseminated under this Agreement, and the two sets of data are not linked in any way. The NHS England dataset also provides data on death registrations for any existing tumour registration since 1974 on an annual basis as part of this annual data extract. Where data on cancer diagnosis and treatment are missing or incomplete from the electronic data sources, the study team manually abstract information from local hospital notes and patient management systems. The data comprises personal and demographic information (e.g. name, date of birth, address, postcode) along with diagnostic and clinical data on treatment (chemotherapy drugs and doses, radiotherapy site and dose, surgery). More recently, enhanced treatment information on chemotherapy and radiotherapy will be obtained through NCRAS, including the national Systemic Anti-Cancer Therapy Dataset (SACT). All data provided form third-party sources are added to the registry at a pseudonymised level. The data provided from NHS Digital is not added to the registry, comparison on participants is made using only a pseudonymised patient ID. No attempt is made to re-identify a participant using either the data from NHS Digital or any data within the registry. Below is a summary of the YSRCCYP research team’s research plans which include the following objectives: Data on 12,000 patients have been collected since 1974, however linked HES and mental health data was required for only 9,000, as the cohort shared with NHS Digital excludes participants who passed away before 1996. The cohort submission under this Agreement will consist of approximately 9,000 patients. 1) To describe the total burden of physical and mental health hospitalisation among the Yorkshire cancer population aged 0-39 years, to identify clinical and sociodemographic factors which influence the likelihood of hospitalisation and to investigate how hospitalisation rates have changed since 1997. The YSRCCYP is a population-based register, inclusion is based on the patient's residential address at diagnosis. Any individuals being treated in Yorkshire hospitals but resident outside the region will be excluded. Those on the register who move away from the Region remain included in case of any follow-up treatment or care. All patient information is retained beyond the age of 30 years for the purpose of tracking their long-term cancer outcomes. 2) To understand patient care pathways through the NHS before, during and after cancer diagnosis. This includes assessment of time to diagnosis for children and young adults diagnosed with cancer under the age of 40 years to identify where improvements can be made to minimise delays in diagnosis leading to better prognosis and less stress and anxiety on patients and their families. The sole data controller is the University of Leeds. The legal basis for dealing with people’s personal data for research data, is ‘task in the public interest’, or in other words, the University are collecting data that they need in order to complete their research, which aims to improve healthcare for the general public. This flow of information falls under GDPR Articles 6(1)(e) and 9(2)(j), and is also covered by the study's section 251 approval from the HRA CAG to permit the common law duty of confidentiality to be temporarily lifted. The justification for processing the data by University of Leeds is Article 6 (1)(e) of the GDPR: (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller). The justification for the processing of the special category data (health data) by University of Leeds is Article 9 (2)(j) of the GDPR: (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. Patients are made aware of all data flows through leaflets distributed at the main Principal Treatment Centres, posters on hospital wards, webinars with the local charity funders (Candlelighters Trust) and the YSRCCYP register website and fair processing statement which is published on the University of Leeds website. The data controller involves members of the public and participants through presentations of results. Feedback from presentations researchers have made to families and cancer survivors, have shown that they are hugely grateful for the Register and research carried out on their behalf. Those attending these presentations felt that they had been sufficiently informed about the research, and are comfortable and supportive of the need to collect and process this data without informed consent. The YSRCCYP research database has its' own Scientific Advisory Group which includes representation from the following areas – university research, public health, clinical medicine, health care professionals, patients and lay persons. The Advisory Group is responsible for ensuring that appropriate procedures are in place to ensure the physical security of the data and its release. The Advisory group do not access or determine how the data under this Agreement will be used and are therefore not deemed to be data controllers. The data under this Agreement will be compared with (but not linked with) data on inpatient hospital admissions and Mental Health data for the general population in Yorkshire under the age of 65 derived from the pseudonymised HES extract, provided under a separate Data Sharing Agreement (reference: NIC-155843-0MQMK). General population data will be compared with a population of the same age range in the cohort who were diagnosed with childhood or young adult cancer. The aim is to assess whether certain hospital admissions are more (or less) common amongst a population of survivors of childhood and young adult cancers following treatment compared to the general population. The risk of admissions of a certain diagnosis in the cancer population will be compared to that in the general population. The YSRCCYP research team aims to look at the whole admission pattern of patients, not simply those that occur in the primary diagnosis fields and therefore require an episode level extract as opposed to aggregated counts of admission. The HES and mental health data are not added into the YSRCCYP research database. The two datasets are stored separately but contain common unique study IDs enabling data to be linked at record level. Where required for specific research, relevant data are extracted from the respective databases, linked and analysed by the YSRCCYP research team. Firstly in order to address aim 1 and 4-6 investigating changes in levels of hospitalisation over time and within specific cancer types, age groups and sociodemographic groups. Secondly to maximise statistical power for analyses given the rarity of childhood and young adult cancer; also to assess changes in access over time to specialist cancer care services, as NHS policy regarding the recommendations for treatment of children and young people with cancer has changed with the opening of Principal Treatment Centres in hospitals across in England throughout this time frame. ~~The YSRCCYP research team’s research plans include the following objectives:~~ 1) To describe the total burden of physical and mental health hospitalisation among the Yorkshire cancer population aged 0-29 years, to identify clinical and sociodemographic factors which influence the likelihood of hospitalisation and to investigate how hospitalisation rates have changed since 1997. 2) To understand patient care pathways through the NHS before, during and after cancer diagnosis. This includes assessment of time to diagnosis for children and young adults diagnosed with cancer under the age of 30 years to identify where improvements can be made to minimise delays in diagnosis leading to better prognosis and less stress and anxiety on patients and their families. [4 paragraphs unchanged] *Please note, the data added to the YSRCCYP from data sources such as ChemoCare, will never be linked to NHS ~~Digital~~ England at record level. Only aggregated outputs with small numbers suppressed will be compared. [10 paragraphs unchanged] A PPI workshop took place in January 2022, organised by the Yorkshire Register research team, DATA-CAN (HDR-UK) and the Children’s Cancer and Leukaemia Group (CCLG) where the YSRCCYP research team sought individuals’ views on opting out for those who were diagnosed with cancer under the age of 19 and who were currently aged 16-24 years. The YSRCCYP research team also invited carers of children with cancer to attend. Participants appeared to be reassured that there was a clear process for opting out but raised the point that by opting out this would cause problems for researchers. There was a strong view that opting out would jeopardise the ability to enable complete data sharing for research purposes in relation to rare cancers so that better treatments can be developed, with fewer side effects and long-term complications In order to meet the above objectives, The University of Leeds request an update to the following NHS England datasets to be supplied at year 3 within this agreement. The YSRCCYP research team require some data items classed as sensitive. These are the Referrer code, which indicates the manner in which the patient was referred to hospital by ascertaining the code of the referring organisation. This allows the YSRCCYP research team to identify particular patient pathways which are associated with an optimal time to diagnosis, a key indicator known to influence survival. Additionally the Consultant code data field is required because it enables the YSRCYYP research team to work out whether patients receive care at specialist cancer centres as opposed to general district hospitals, in order to address important health services research questions such as: ‘Does specialist care improve patient outcomes for children and young people including length of hospital stay and reduce subsequent morbidity and mortality?’. There are currently no databases which link consultant codes to specialist cancer centres for childhood and young adult cancer, so this process needs to be done manually using cohort linked NHS Digital data and the YSRCCYP database. -Mental Health Services Data Set (MHSDS) ~~UofL are keen to access data by gender, deprivation, ethnicity (South Asian, Black, White, other) as well as age to allow them to draw accurate comparisons with the cancer cohort.~~ -Mental Health and Learning Disabilities Data Set (MHLDDS) -Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set -Hospital Episode Statistics Admitted Patient Care (HES APC) -Hospital Episode Statistics Outpatients (HES OP) -Emergency Care Data Set (ECDS) -Hospital Episode Statistics Accident and Emergency (HES A and E) The University of Leeds request an update to the following NHS England (NDRS) datasets to be supplied on an annual basis. (Data previously disseminated under DARS-NIC-656761): -Civil Registration Mortality – necessary to calculate survival estimates to examine early mortality and long-term trends in survival for the YSRCCYP cohort. -NDRS Cancer Registration – necessary to ensure that the YSRCCYP has complete case ascertainment for all patients aged under 40 years in Yorkshire, as well as any subsequent tumours or relapses. -NDRS National Radiotherapy Dataset (RTDS) -NDRS Systemic Anti-Cancer Therapy Dataset (SACT) The level of data will be identifiable necessary to enable linkage of the data with data collected from other sources within the YSRCCYP (local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs). In order to evaluate long-term health and social outcomes. Identifiable data items are essential so that the YSRCCYP data manager can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information. The data will be minimised as follows: • Limited to data for the YSRCCYP cohort identified by the University of Leeds, i.e. patients aged 0-14 years diagnosed with cancer in Yorkshire & the Humber between 1974-1989 and patients aged 0-39 years since 1990. • All valid ICD10 codes for cause of death. • ICD10 codes C00 – C97, D00-D05, D07-D48 for second primary tumours. The University of Leeds is the research sponsor and the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. This processing is in the public interest because it relates to cancer registration, specifically to examine long-term health and social outcomes for children and young people diagnosed in Yorkshire. Findings will provide information on those groups whose outcomes are worse than their peers and this will be used to inform future decisions over patients’ treatment and care. The funding is provided by the Candlelighters Trust, Leeds. The funding is specifically for the YSRCCYP cohort described. Funding is in place until 31/5/2027. The funder will have no ability to suppress or otherwise limit the publication of findings. The YSRCCYP database is currently stored on the University of Leeds's cloud platform called LASER which is provided by Microsoft Limited. It is anticipated The University of Leeds will migrate the data to AIMES Management Services in 2024, to which an amendment to this DSA to update the processor as required will be submitted. Microsoft Limited provides IT hosting services to the University of Leeds and will store the data as contracted by the University of Leeds. Microsoft Limited also provides IT back up services to the University of Leeds and will store copies of the data as contracted by the University of Leeds. Data will be accessed by: • Undergraduate, Masters or PhD students affiliated with the University of Leeds. Any student working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to the University of Leeds’ policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of a substantive employee of the University of Leeds. The University of Leeds would be responsible and liable for any work carried out by students. These students would only work on the data for the purposes described in this Agreement. Any education benefit gained from carrying out this work would be an associated benefit and would not be the primary reason for the research being conducted nor the primary reason for their involvement. • An individual from Hull University Teaching Hospitals NHS Trust will be working on specific data extracts for their own clinical academic training, holding an honorary contract (visiting title) with the University of Leeds. The honorary contract holder is a junior doctor who requires research experience as part of their clinical academic training in order for them to continue with their career. They will be performing the statistical analysis for the study. An appropriate contract between the individual and the University of Leeds is in place. Any individual working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to the University of Leeds’ policies on data protection and confidentiality. Any individuals accessing the data will do so under the supervision of a substantive employee of the University of Leeds. The University of Leeds would be responsible and liable for any work carried out by these individuals. These individuals would only work on the data for the purposes described in this Agreement. Any education or clinical academic benefit gained from carrying out this work would be an associated benefit and would not be the primary reason for the research being conducted nor the primary reason for their involvement. The YSRCCYP Scientific Advisory Group provides advice on key strategic objectives, monitors progress on these objectives, monitors the quality of the scientific work of the project and provides guidance on complex issues when needed, e.g. the release of sensitive findings. Details of current members can be found on the YSRCCYP website: https://ysrccyp.org.uk/about/scientific-advisory-group/. The NIHR Clinical Research Fellow within the YSRCCYP team, has led on the development of two national Public and Patient Information and Engagement workshops in February 2022 and April 2022 in conjunction with DATA-CAN exploring young people’s views on the use of health data for research purposes. This included discussion around cancer registration and data linkage with education and employment datasets. There was strong support from the group in favour of these ongoing research activities and these findings are being written-up for publication later this year. The workshops also helped to inform the research strategy because the late effects of cancer were also one of the young people's research priorities. These young people are also supporting University of Leeds in individual research projects and grant applications. The NIHR Clinical Research Fellow and the Register Statistician, have also represented the work of the YSRCCYP and Candlelighters’ Trust at the ‘Be Curious’ public engagement event for children and their families held at the University of Leeds in May 2023. This was a huge success with numerous families asking questions about the research and expressing interest about being involved in future PPIE events related to the YSRCCYP. There was significant diversity of families attending the event, for example children attended from the Bradford East family hub along with families where English was their second language. This provided University of Leeds with the ability to engage with the harder to reach populations. Patients are made aware of all data flows through leaflets distributed at the main Principal Treatment Centres, posters on hospital wards, webinars with the local charity funders (Candlelighters Trust) and the YSRCCYP register website and fair processing statement which is published on the University of Leeds website. University of Leeds have also engaged with groups such as the GenerationR Young People’s Advisory Group at Leeds General Infirmary where the research from the YSRCYP is disseminated to young people in accessible forms. This contract is reliant on the Data Recipient maintaining the continued support for use of confidential patient information without consent, according to regulations made under section 251 of the NHS Act 2006 (20CAG0133). The study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Processing activities

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). For NDRS linkage, NHS England will provide the relevant records already flagged from the NDRS dataset to the University of Leeds in terms of latest vital status i.e. death registration data, relapse, secondary malignant neoplasms and any subsequent treatment received. NHS England will also provide relevant records on all new cancer registrations aged 0-39 years at diagnosis resident in Yorkshire as well as the same details listed in the previous sentence. NHS England will flow back identifiable data such as NHS number, full name, date of birth, sex and postcode so that University of Leeds can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information. These identifiers are stored and then used to enable data linkage with information collected from other sources such as local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs) data as described in the YSRCCYP data flow diagram, as part of the epidemiological research programme to monitor long-term health and social outcomes. ~~The YSRCCYP research team undertake the following processing activities:~~ For HES linkage, the registration data will flow from University of Leeds back to NHS England and will contain directly identifying data items including NHS Number, Date of Birth, Postcode, and Gender which are required to link the data at record level with data already held by the NDRS. NHS England will then flow back the linked HES data with the YSRCCYP tumour identifier number to University of Leeds. The University of Leeds will securely transfer files of identifiers for patients in the YSRCCYP (NHS Number, Date of birth, sex and postcode plus a unique study ID) to NHS Digital. NHS Digital will return HES data up to the period 2021/22 latest available including the unique study ID and no other identifiers. Data will be stored on Leeds Analytic Secure Environment for Research (LASER), a custom Virtual Research Environment (VRE) based on Microsoft Azure technologies operated by the University of Leeds. LASER uses the Microsoft Azure UK South data centre. ~~On receipt of cohort linked data the YSRCCYP research team undertake the following processing activities:~~ https://lida-data-analytics-team.github.io/laserdocs/docs/laser_info/laser.html. The data are initially checked for any errors or inconsistencies. This involves checking to ensure no duplicate episodes remain, which may have arisen either due to supplied duplicate HES episodes or the overlap between previously received HES data by the YSRCCYP research team, some of which may relate to provisional data releases. Further checks are made to ensure no multiple admissions existed which were less than 2 days apart with the same HES ID, and no admission entries occurred after the date of death if deceased (the latter which is obtained from YSRCCYP database). Backups are handled by Microsoft Azure Recovery Services (MARS) agent and uses a Backup Service Vault, connected to Azure storage services based in the UK. Upon completion of checks, an extract of identifiable data (not NHS Digital data) is taken from the YSRCCYP database and linked to fields from the cohort linked HES data (pseudonymised) to calculate variables such as the duration from admission to death and age at admission where such variables are relevant to specific research questions. As per the University of Leeds policy data is classified using a data risk tiering system based on the perceived impact of disclosure. All data from projects like the YSRCCYP generally falls within tier 3 or 4. Identifiable data is generally classified as tier 4, i.e. significant impact to University of Leeds, partners or individuals with potential for substantial legal, financial or reputational penalties. Pseudonymised / De-identified data is generally classified as tier 3, i.e. high impact to University of Leeds, partners or data subjects with potential for contractual, commercial, legal, financial or reputational penalties. Length of hospital stay is calculated from the dates of admission and discharge and compared between cancer diagnostic groups, age groups, gender, ethnic group, socioeconomic status, level of specialist care, and distance from residential address to hospital (hence why the University needs OA code and grid reference). Identifiable data is held within a separate VRE that can only be accessed from within a designated safe room onsite at the University of Leeds. Pseudonymised data is held in a separate VRE that can be accessed by authorised personnel remotely. Data ingress and egress of all data is controlled by the LASER Data Analytics Team (DAT). https://lida-data-analytics-team.github.io/laserdocs/docs/lida_services/dat.html. Research staff do not have the ability to copy any dataset to an external device. All data is held locally at the University of Leeds, on encrypted hard drives, in a highly secure environment. Extreme care and attention is paid to maintaining the security and confidentiality of the YSRCCYP research database. The identifiable data will not leave England at any time and the data will not be transferred to any other location. ~~In summary the following physical precautions are in place to protect the data under this Agreement:~~ The Data will be accessed by authorised personnel via remote access. The Data will remain on the servers at Leeds Analytic Secure Environment for Research (LASER), at all times. ~~· Only those essential members of staff who work on the YSRCCYP research database and require direct access to the data are granted authorisation.~~ The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. · All users of the LASER system must sign a confidentiality agreement, which includes stipulating that security and confidentiality must be maintained. Certain breaches of security could lead to disciplinary and legal action being taken. For remote access: ~~· The data is held on an encrypted firewall-protected area of the University of Leeds IRC.~~ - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; ~~· Daily back-ups are taken to ensure the integrity of the data and held off-site.~~ - Access controls granting users the minimum level of access required are in place; ~~Personally identifiable information is held subject to the following conditions:~~ - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; ~~· No information is ever published in which individuals can be identified.~~ - Multifactor authentication (MFA) is required for remote access; ~~· No individuals on the YSRCCYP research database are ever approached directly.~~ - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; ~~· Data are only released according to the requirements of the Information Governance Policy which specifies the circumstances for data release.~~ - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy. Data will be held indefinitely enabling the accrual of an ever-increasing dataset relating to cancer in young people and allowing more powerful statistical comparisons to be performed and the effects of risk factors estimated more precisely. Access is restricted to individuals within the YSRCCYP research team at the University of Leeds who have authorisation from the Principal Investigator (PI). All such individuals are substantive employees of the University of Leeds, Undergraduate, Masters or PhD students affiliated with the University of Leeds. An individual from Hull University Teaching Hospitals NHS Trust will be working on specific data extracts for their own clinical academic training, holding an honorary contract (visiting title) with the University of Leeds. The University of Leeds presently stores the data on an encrypted secure area network (SEED), however under this version of this Agreement The University of Leeds is requesting to migrate the data to Microsoft Azure. Access to data stored on the cloud will be restricted to individuals working on the YSRCCYP register research programme. Access to the record level data will only be by substantive employees of the University of Leeds and located within the Leeds Institute for Data Analytics (School of Medicine). No NHS Digital data will be transferred outside of the University of Leeds or shared with any third-party individual or organisation. Access to each pseudonymised / de-identified dataset held will be restricted to designated YSRCCYP affiliated researchers who have been authorised by either the PI or designated officer. Access to patient identifiable data is restricted to employees of the University of Leeds who are YSRCCYP affiliated. These researchers will have specifically been granted access by the PI dependent on their job role. YSRCCYP researchers can potentially have prepared identifiable datasets in locations within the VRE with bespoke access restrictions to minimise the individuals with access to the full identifiable data held. Individuals with an honorary contract / visiting title act as an agent of the University of Leeds at all times under supervision of University employees. The cohort linked data (HES and mental health) and the pseudonymised HES extract, provided under a separate Data Sharing Agreement (reference: DARS-NIC-155843-0MQMK), are stored separately but contain common unique study IDs enabling data to be linked at record level. Both datasets are distinct from the YSRCCYP data itself. The pseudonymised HES extract will not be linked to the cohort data supplied by NHS Digital or in the YSRCCYP database. Different pseudonymised HES IDs will ensure this is not possible. Access to the core identifiable dataset will be restricted to a minimum number of individuals within the YSRCCYP research team. Research data extracts will be approved by data managers and research statisticians within the team. A data asset log will be maintained documenting the source / code used to produce use, storage location and approved users. All requests are approved by the Principal Investigator via email, which acts as an additional audit trail. The HES and mental health data disseminated under this agreement are not added into the YSRCCYP research database. The two datasets are stored separately but contain common unique study IDs enabling data to be linked at record level. Where required for specific research, relevant data are extracted from the respective databases, linked and analysed by the YSRCCYP research team. All personnel accessing the data have been appropriately trained in data protection and confidentiality. Data will only be used for the purposes described in this Agreement. The NHS Digital data will not be linked to any other data apart from YSRCCYP data (including linked data as listed on the Data Flow Diagram), however NHS Digital data will never be uploaded to the YSRCCYP research database. [1 paragraph unchanged] The data will be linked at person record level with datasets obtained from NHS England (NDRS & HES), Leeds Teaching Hospitals NHS Trust (PPM; PROMs), Department for Education (National Pupil Database), Department for Work and Pensions, and HMRC. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Data managers and researchers from the YSRCCYP research team at the University of Leeds will process the data for the purposes described above. Researchers from the YSRCCYP research team at the University of Leeds will use the relevant subset of data to analyse incidence and survival trends including long-term health and outcomes, as described above.

Expected output

Summaries of the results will be presented orally at conferences and are intended to be published in academic or medical journals. All outputs will be aggregated with small numbers suppressed and in line with the HES Analysis Guide. The expected outputs of the processing will be: Work describing risks of health effects of treatment in relation to respiratory illnesses was completed by the YSRCCYP research team and published in International Journal of Cancer in 2020. Work describing the applicability of risk-stratified levels of aftercare in predicting long-term morbidity in young adults was completed by the YSRCCYP research team and published in the Journal of Cancer Survivorship in 2020 Work describing risks of health effects of treatment in relation to the cumulative burden of subsequent neoplasms, cardiovascular and respiratory morbidity was completed by the YSRCCYP research team and published in Cancer Epidemiology in 2020. • A report of findings to the Candlelighters Trust on an annual basis. Further outputs will be disseminated in open-access journals (e.g. BMC Cancer) and presented at conferences including the National Cancer Registration and Analysis Service Cancer Outcomes annual meeting, Teenage Cancer Trust and the International Society of Paediatric Oncology annual conferences. Analyses describing educational outcomes will be submitted for publication by Summer 2023 to the International Journal of Cancer (or similar). • Submissions to peer reviewed journals, expected to be at least two submissions per year. Work will be submitted to the European Journal of Cancer (or similar) in relation to specific cardio-metabolic disease by Summer 2024. Risks of kidney toxicity will be submitted for publication by Summer 2024 in the British Journal of Cancer (or similar) by Summer 2024. Risks of anxiety, depression and overall mental health disorders will be submitted for publication by Winter 2024 in the International Journal of Cancer (or similar). • Presentations to the Candlelighters Trust as well as local and regional clinical and research seminars. Details of risk stratification models and the methodology to derive these for individual patients will be disseminated by the research team to every clinician involved in the care of children and young people (CYP) in August 2024. This will be supported by the Yorkshire & Humber CYP cancer network that holds details of all practicing NHS CYP cancer teams and clinicians in the region. • Presentations at Cancer Research UK, National Cancer Registration and Analysis Service Cancer Outcomes annual meeting, Teenage Cancer Trust and the International Society of Paediatric Oncology annual conferences. • Publication of infographics on the YSRCCYP’s website: www.ysrccyp.org.uk. • A database to be utilised as a resource for health research. The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. The outputs will be communicated to relevant recipients through the following dissemination channels: • Journals (e.g. BMC Cancer) • Workshops involving clinicians and researchers working in the childhood and young adult cancer field, e.g. NCRI TYA and Germ Cell tumour Clinical Services Group. • Webinars open to academic and clinical researchers in the UK. • Social media • Posters displayed at Cancer Research UK, CCLG, TYAC and SIOP conferences. • Patient Information leaflets available at the YSRCCYP website: www.ysrccyp.org.uk. • Press/media engagement • Public promotion of the research, e.g. Be Curious event at the University of Leeds. The target dates for production and dissemination of the outputs are: • Journals: 2 per year, e.g. germ cell tumour dose intensity paper to be submitted by July 2023, early mortality paper to be submitted by Dec 2024, cardio-metabolic paper to be submitted by Dec 2024. Analyses describing educational outcomes will be submitted for publication by Summer 2025 to the International Journal of Cancer (or similar). Work will be submitted to the European Journal of Cancer (or similar) in relation to specific cardio-metabolic disease by Summer 2025. Risks of kidney toxicity will be submitted for publication by Summer 2024 in the British Journal of Cancer (or similar). Risks of anxiety, depression and overall mental health disorders will be submitted for publication by Winter 2025 in the International Journal of Cancer (or similar). • Workshops involving clinicians and researchers working in the childhood and young adult cancer field, e.g. NCRI TYA and Germ Cell tumour Clinical Services Group: 3 per year. • Webinars open to academic and clinical researchers in the UK: 2 per year. • Social media: coinciding with each journal publication, 2 per year. • Posters displayed at Cancer Research UK, CCLG, TYAC and SIOP conferences: 3 per year. • Patient Information leaflets available at the YSRCCYP website: www.ysrccyp.org.uk: ongoing and updated regularly. • Press/media engagement: coinciding with each journal publication, 2 per year. • Public promotion of the research, e.g. Be Curious event at the University of Leeds: twice per year. Details of risk stratification models and the methodology to derive these for individual patients will be disseminated by the research team to every clinician involved in the care of children and young people (CYP) in August 2025. This will be supported by the Yorkshire & Humber CYP cancer network that holds details of all practicing NHS CYP cancer teams and clinicians in the region. The linked NHS Digital data alongside the background hospitalisation rates will be used to derive key information which will be provided by the YSRCCYP research team to clinicians involved in the long-term care of young people identifying each individual’s risk stratification group (defined as being at ‘low’, ‘medium’, or ‘high’ risk of future complications or health effects, based upon their previous hospital activity patterns, treatment mortality, dose, cancer type and stage). The risk stratification model will be devised by the YSRCCYP research team and disseminated to clinicians in the Yorkshire and Humber region via the Y&H Children’s and Young People’s Cancer Network (August 2025). Only those clinicians involved in the direct care of individuals with cancer will be provided with details of the risk stratification model. Health care commissioners will be provided with aggregated cancer intelligence data on the number of survivors currently being seen at each NHS Trust according to risk stratification group, so future services can be planned effectively (Summer 2025). [2 paragraphs unchanged] The linked NHS Digital data alongside the background hospitalisation rates will be used to derive key information which will be provided by the YSRCCYP research team to clinicians involved in the long-term care of young people identifying each individual’s risk stratification group (defined as being at ‘low’, ‘medium’, or ‘high’ risk of future complications or health effects, based upon their previous hospital activity patterns, treatment mortality, dose, cancer type and stage). The risk stratification model will be devised by the YSRCCYP research team and disseminated to clinicians in the Yorkshire and Humber region via the Y&H Children’s and Young People’s Cancer Network (August 2024). Only those clinicians involved in the direct care of individuals with cancer will be provided with details of the risk stratification model. Health care commissioners will be provided with aggregated cancer intelligence data on the number of survivors currently being seen at each NHS Trust according to risk stratification group, so future services can be planned effectively (Summer 2024). Data will be held for as long as the research project is funded to undertake this piece of epidemiological and applied health research. Current funding expires on 31st May 2027. Subject to securing ongoing funding, the data would be retained until December 2027 to allow sufficient time for completion of analyses, submission and final publication of papers. Results will be reported to academic audiences in peer reviewed journal articles and conference presentations. The study also plan to disseminate findings directly to other beneficiaries including cancer patients, their families and clinicians. Data will be held for as long as the research project is funded to undertake this piece of epidemiological and applied health research. Current funding expires on 31st August 2027. Subject to securing ongoing funding, the data would be retained until December 2027 to allow sufficient time for completion of analyses, submission and final publication of papers.

Expected measurable benefits

~~The benefits to health and social care will include:~~ The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to childhood and young adult cancer. 1. Improved patient care. This work will aim to identify to clinicians those individuals within the cohort who are at greatest risk of hospitalization; this will enable follow-up practices to be tailored to patient needs, help identify potential health problems early and intervene so that patient wellbeing is maximized and NHS burden minimized. For example, those individuals identified as being at greatest risk of cardio-metabolic, mental health and kidney illness will be offered additional support from NHS services (e.g. psychiatry, social care) through their treating oncologist or GP. The risks of depression following cancer treatment will help to describe the NHS burden of mental health problems in this vulnerable population. This knowledge will be informative to paediatric oncologists and other allied health professionals caring for patients, as well as their GPs, by improving awareness of the timing when depression is likely to be diagnosed so that the quality of care can be improved. Patients will be informed of their risk group via their treating consultant or at their annual hospital clinic follow up appointment. Their GPs will also be informed of the results of the risk stratification via the hospital consultant team. The use of the data could: 2. Evaluation of treatments to identify best practice and guidance. Work to understand the reasons for the hospitalisation so researchers can identify whether certain treatments are associated with an increased risk of hospitalisation and disseminate this information through scientific journal articles. This will mean that alternative treatment modalities and optimal care can be planned which minimize these complications. Anticipated dates to complete these activities are by Summer 2024. • help the system to better understand the health and care needs of the childhood and young adult cancer population in Yorkshire. 3. Evaluation of service provision. Highlight any inequalities in access to specialist cancer care services, particularly in older teenagers and young adults, so that all patients have an equal chance of obtaining the best care irrespective of their personal circumstances and thereby having the best chance of cure. The work will be written up in the form of reports to commissioners and journal articles so that clinicians and commissioners can use this information in order to make any necessary changes to service delivery so that the entire Yorkshire and Humber cancer population is served equally well. Anticipated dates to complete these activities are by December 2024. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. 4. Financial planning. Information on hospital activity burden and NHS costs associated with the diagnosis and treatment of children and young adults with cancer will be calculated by the University research team in collaboration with health economists at the Leeds Institute of Health Sciences. Changes in costs over the last 20 years will be reported, adjusting for inflation, in order to provide cost projections over the next 10 years. This information will be collated in the form of a report to specialist commissioners of childhood and adolescent cancer services in the Yorkshire & Humber region so that, where required, service changes can be implemented in order to meet future NHS patient demand. Anticipated dates to complete these activities are by December 2025. • advance understanding of regional trends in health and social care needs. ~~At the moment, these data are lacking and once identified by the YSRCCYP research team, they will provide important information:~~ • inform planning health services and programmes, for example to improve equity of access, experience and outcomes for children and young people with cancer. * to clinicians top improve the treatment of cohort patients under their care • provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed. * to specialist commissioners to monitor the effectiveness of cancer care and Potential benefits could comprise: * to patients in order to understand more about their own risks of complications associated with the treatment they have received and wherever possible self-manage their own care and wellbeing. • An ability to evaluate changes in risk of death for children and young people diagnosed with cancer in Yorkshire and determine whether differences exist by ethnic group, deprivation and stage at diagnosis. * to identify gaps in access to specialist care by the research team for two distinct populations: • Identify those groups of survivors who are most likely to experience the poorest health and social outcomes so that appropriate interventions and improvements in care quality can be devised. ~~i) teenagers and young adults, who do not benefit from the same level of centralised care as that in place for younger children, and~~ It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to childhood and young adult cancer patients and survivors in Yorkshire. Outputs will be integrated into clinical practice through established links between the YSRCCYP research team and paediatric and adolescent oncologists throughout the Yorkshire region. The research programme as a whole benefits enormously from the long-running, close collaboration with haematologists and oncologists in the Yorkshire and the Humber region who all help to ensure that the University's research findings are effectively translated into clinical practice and are involved in all outputs from the YSRCCYP database. University of Leeds will use multiple channels to disseminate key findings. These will include: • The Candlelighters Trust Families Group • The CCLG’s Late Effects Group • The NCRI CTYA and Germ Cell Tumour Clinical Services Group • PPIE events such as those organised by the Candlelighters Trust and University of Leeds, e.g. Be Curious. • International scientific meetings, e.g. SIOP, Global AYA Cancer Congress. • The YSRCCYP website: www.ysrccyp.org.uk. The Candlelighters Trust, as the main funder of the YSRCCYP research programme, have been an important source of support in making sure that the outputs are provided in clear formats and at appropriate public meetings

Benefits reported

~~The YSRCCYP database has yielded several benefits, for example:~~ Update as provided on the annual confirmation report submitted 21/12/2023 • The data collected as part of the YSRCCYP has allowed researchers to better understand the burden on NHS services of late cardiovascular and respiratory morbidity as well as second cancers survivors and quantifies the long-term risk of such morbidity for survivors and healthcare professionals looking after them. It has enabled childhood and young adult cancer survivors and their families to understand more about their own risk of developing these longer-term health problems according to their original diagnosis and treatment, and at what age they are most likely to appear. In effect, young cancer patients have been able to take ownership of their own survivorship. Multiple peer-reviewed publications describing the epidemiology and long-term outcomes for children and young people diagnosed with cancer in Yorkshire. • The YSRCCYP database has facilitated the production of an up-to-date summary of the latest literature relating to late consequences of cancer treatment on reproductive health, describing the impact on both fertility and pregnancy. This has provided awareness and information to cancer survivors from Yorkshire about reproductive outcomes to enable them to plan fertility storage at the earliest opportunity and maximise the chances of having their own offspring. Additionally, the identification of a sparsity of evidence on outcomes of ovarian and testicular tissue resulted in establishment of a multi-centre initiative to establish a population based register of individuals with stored ovarian and testicular tissue in the United Kingdom (UK). A full list can be found here: • It has allowed researchers to quantify respiratory morbidities, treatment-related risks and their relationship to subsequent morbidity and mortality among long-term survivors of childhood and young adult cancer in Yorkshire. This information has been made available to the clinical community in Yorkshire in the form of research papers, regular webinars and infographics so that those health professionals looking after young cancer survivors are able to inform them of their risks of morbidity depending on their original cancer diagnosis and treatment, and at what age these are likely to be develop.. https://ysrccyp.org.uk/research/publications/ • It has allowed researchers to quantify the prevalence and spectrum of mental health problems found in adult survivors of childhood cancer, based on a systematic review of the current evidence. Problems ranged from depression, anxiety, behavioural problems and drug misuse. Factors increasing the likelihood of mental health problems included treatment with high-dose anthracyclines, cranial irradiation, diagnoses of sarcoma or central nervous system tumours and ongoing physical ill health. The review recommended further work to identify childhood cancer patients who are at risk of developing late mental health morbidity. Some specific examples: • The first comprehensive analysis of hospital mental health episodes following CTYA cancer treatment (Friend, PhD thesis, 2020), preceded by a systematic review of the current evidence (Friend et al, Int J Cancer 2018). 1) The data collected as part of the YSRCCYP has allowed researchers to better understand the burden on NHS services of late cardiovascular and respiratory morbidity as well as second cancers survivors and quantifies the long-term risk of such morbidity for survivors and healthcare professionals looking after them. It has enabled childhood and young adult cancer survivors and their families to understand more about their own risk of developing these longer-term health problems according to their original diagnosis and treatment, and at what age they are most likely to appear. In effect, young cancer patients have been able to take ownership of their own survivorship. • The YSRCCYP research team found that the National Cancer Survivorship Initiative paediatric late-effects risk stratification system can be effectively and safely applied to cancer patients aged 18-29, independent of ethnicity or socioeconomic position. This evidence has supported clinical services in Yorkshire and further afield across the UK to safely adopt risk-stratified care pathways for the long term follow up of individuals living with and beyond cancer. 2) The YSRCCYP database has facilitated the production of an up-to-date summary of the latest literature relating to late consequences of cancer treatment on reproductive health, describing the impact on both fertility and pregnancy. This has provided awareness and information to cancer survivors from Yorkshire about reproductive outcomes to enable them to plan fertility storage at the earliest opportunity and maximise the chances of having their own offspring. Additionally, the identification of a sparsity of evidence on outcomes of ovarian and testicular tissue resulted in establishment of a multi-centre initiative to establish a population based register of individuals with stored ovarian and testicular tissue in the United Kingdom (UK). 3) It has allowed researchers to quantify respiratory morbidities, treatment-related risks and their relationship to subsequent morbidity and mortality among long-term survivors of childhood and young adult cancer in Yorkshire. This information has been made available to the clinical community in Yorkshire in the form of research papers, regular webinars and infographics so that those health professionals looking after young cancer survivors are able to inform them of their risks of morbidity depending on their original cancer diagnosis and treatment, and at what age these are likely to be develop. 4) It has allowed researchers to quantify the prevalence and spectrum of mental health problems found in adult survivors of childhood cancer, based on a systematic review of the current evidence. Problems ranged from depression, anxiety, behavioural problems and drug misuse. Factors increasing the likelihood of mental health problems included treatment with high-dose anthracyclines, cranial irradiation, diagnoses of sarcoma or central nervous system tumours and ongoing physical ill health. The review recommended further work to identify childhood cancer patients who are at risk of developing late mental health morbidity. 5)The first comprehensive analysis of hospital mental health episodes following CTYA cancer treatment (Friend, PhD thesis, 2020), preceded by a systematic review of the current evidence (Friend et al, Int J Cancer 2018). 6)The YSRCCYP research team found that the National Cancer Survivorship Initiative paediatric late-effects risk stratification system can be effectively and safely applied to cancer patients aged 18-39, independent of ethnicity or socioeconomic position. This evidence has supported clinical services in Yorkshire and further afield across the UK to safely adopt risk-stratified care pathways for the long term follow up of individuals living with and beyond cancer.

Objective for processing

Childhood cancer registration details for those aged 0-15 years are primarily provided via the two Principal Treatment Centres, at Leeds Children’s Hospital and Sheffield Children’s Hospital, with a secondary source being the NCRAS. For 16-39 year olds, these are primarily provided by the NCRAS, with secondary sources being Teenage and Young Adult Principal Treatment Centres in Leeds and Sheffield. The NCRAS is also the primary source of information for these children and young people if diagnosed with any subsequent tumours or relapses at any age and living inside or outside the Yorkshire region at the time.

The NHS England dataset also provides data on death registrations for any existing tumour registration since 1974 on an annual basis as part of this annual data extract.

Below is a summary of the YSRCCYP research team’s research plans which include the following objectives:

In order to meet the above objectives, The University of Leeds request an update to the following NHS England datasets to be supplied at year 3 within this agreement.

-Mental Health Services Data Set (MHSDS)

-Mental Health and Learning Disabilities Data Set (MHLDDS)

-Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set

-Hospital Episode Statistics Admitted Patient Care (HES APC)

-Hospital Episode Statistics Outpatients (HES OP)

-Emergency Care Data Set (ECDS)

-Hospital Episode Statistics Accident and Emergency (HES A and E)

The University of Leeds request an update to the following NHS England (NDRS) datasets to be supplied on an annual basis. (Data previously disseminated under DARS-NIC-656761):

-Civil Registration Mortality – necessary to calculate survival estimates to examine early mortality and long-term trends in survival for the YSRCCYP cohort.

-NDRS Cancer Registration – necessary to ensure that the YSRCCYP has complete case ascertainment for all patients aged under 40 years in Yorkshire, as well as any subsequent tumours or relapses.

-NDRS National Radiotherapy Dataset (RTDS)

-NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

The level of data will be identifiable necessary to enable linkage of the data with data collected from other sources within the YSRCCYP (local Patient Managements systems (PPM), HES, National Pupil Database, Department for Work and Pensions (DWP), HMRC and Patient Reported Outcome Measures (PROMs). In order to evaluate long-term health and social outcomes. Identifiable data items are essential so that the YSRCCYP data manager can access the right person’s medical records and validate key information such as cancer diagnosis, staging and treatment whilst addressing any missing information.

The data will be minimised as follows:

• All valid ICD10 codes for cause of death.

• ICD10 codes C00 – C97, D00-D05, D07-D48 for second primary tumours.

The University of Leeds is the research sponsor and the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Data will be accessed by:

The NIHR Clinical Research Fellow within the YSRCCYP team, has led on the development of two national Public and Patient Information and Engagement workshops in February 2022 and April 2022 in conjunction with DATA-CAN exploring young people’s views on the use of health data for research purposes. This included discussion around cancer registration and data linkage with education and employment datasets. There was strong support from the group in favour of these ongoing research activities and these findings are being written-up for publication later this year. The workshops also helped to inform the research strategy because the late effects of cancer were also one of the young people's research priorities. These young people are also supporting University of Leeds in individual research projects and grant applications.

The NIHR Clinical Research Fellow and the Register Statistician, have also represented the work of the YSRCCYP and Candlelighters’ Trust at the ‘Be Curious’ public engagement event for children and their families held at the University of Leeds in May 2023. This was a huge success with numerous families asking questions about the research and expressing interest about being involved in future PPIE events related to the YSRCCYP. There was significant diversity of families attending the event, for example children attended from the Bradford East family hub along with families where English was their second language. This provided University of Leeds with the ability to engage with the harder to reach populations.

This contract is reliant on the Data Recipient maintaining the continued support for use of confidential patient information without consent, according to regulations made under section 251 of the NHS Act 2006 (20CAG0133).

The study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent.