YORKSURe: Early detection of bladder cancer in Yorkshire: Feasibility assessments for implementing a targeted study in populations with high disease specific mortality risk (Cohort Matched)

University of Sheffield requires access to NHS England data for the purpose of the following research project:

YORKSURe: Early detection of bladder cancer in Yorkshire: Feasibility assessments for implementing a targeted study in populations with high disease specific mortality risk (Line Listing)

The following is a summary of the aims of the research project provided by University of Sheffield:

Bladder cancer (BCa) is a common malignancy and one of the most expensive to manage. Whilst demographic reports suggest BCa is the 9th commonest cancer in the UK, these data miss most new diagnoses (as they exclude non-muscle invasive (NMI) cancers). BCa rates increase with age, smoking and occupational carcinogen exposure. Many BCa’s present late to healthcare professionals, as the symptoms mirror those of common benign conditions, such as cystitis or changes in bladder function secondary to prostatic growth or detrusor overactivity. Consequently, BCa incidence and mortality patterns often match local risk factor exposure. In 2017, Yorkshire had the highest incidence of BCa in England and some of the highest mortalities rates. In contrast to most human malignancies, the disease specific survival for BCa is not improving, suggesting a need to change care paradigms. Earlier diagnosis in populations with high mortality risk offers the opportunity for improved survival. Most BCa’s are diagnosed in persons with visible haematuria (VH) or non-visible haematuria (NVH). As such, there is potential to use haematuria to detect asymptomatic disease earlier than would occur otherwise. However, there have been few attempts at screening for BCa using haematuria. Two non-randomised single arm studies found haematuria testing in asymptomatic persons leads to earlier stage of cancers at detection and may improve survival. Britton et al. screened 2,356 British men and found 17 BCa’s, of which all were NMI. At 7 years, 33% of the high-grade NMI cohort had died from BCa, reflecting potential undermanagement of this aggressive cancer. Messing et al. screened 1,575 American men and found a lower stage at diagnosis, with reduced BCa mortality rate (0%) from screening compared to men from a matching statewide registry (16.4% mortality rate). The authors concluded that screening did reduce mortality, but it needs to be applied in high-risk populations (for it to be cost-effective) and that haematuria is intermittent in BCa patients. In populations exposed to aristolochic acid, Zlotta et al. found survival (0% mortality) occurred only with screening (100% mortality in non-screened patients). YORKSURe is a feasibility trial aimed at the early diagnosis of BCa through the detection of NVH in asymptomatic individuals at high risk of mortality from BCa. Following results of the feasibility trial, the aim is to then conduct a large-scale trial, with sufficient power to test any differences in survival. However, to undertake this successfully, we need to understand if our proposed approach is robust, appropriate, necessary, and acceptable to participants.

The following NHS England Data will be accessed:

• NDRS Cancer Consolidated Data

• NDRS Cancer Registrations

These datasets are necessary to calculate incidence rates and compare this to the consented cohort

The level of the Data will be :

• Pseudonymised

The Data will be minimised as follows:

• All bladder cancer incidence events for men aged between 65 – 79 years old.

• These individuals should be located within the following sub-ICB locations (NHS SOUTH YORKSHIRE ICB: 03N – Sheffield, 03L – Rotherham and 02X – Doncaster).

• They should have no previous diagnosis of bladder cancer, kidney cancer or a diagnosis of any other cancer within 5 years (except non-melanoma skin cancer).

University of Sheffield is the research sponsor and the 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 adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care

The funding is provided by Yorkshire Cancer Research. The funding is specifically for the project described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Queen Mary’s University of London (QMUL) is a processor acting under the instructions of University of Sheffield.

ARO will process data on behalf of QMUL including the provider for the Data Safe Haven (DSH). ARO provide a UK cloud environment for processing sensitive data.

Data will be accessed by:

Masters or PhD students enrolled with Queen Mary University of London. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to Queen Mary University of London's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of Queen Mary University of London. Queen Mary University of London 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 DSA

Individuals holding an honorary contract under the supervision of a substantive employee of Queen Mary University of London for the purposes described in this DSA only. Queen Mary University of London must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

• Their substantive employer;

• Their role in respect of the purpose for the processing specified in the DSA;

• The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

• The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

• Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

YORKSURe PPI representatives supported the collection and use of this data, recognising its potential to inform improvements in cancer diagnosis, treatment and patient care. Their insights helped strengthen the clarity and transparency of the application and ensured the patient voice was reflected throughout. They also contributed to the development of participant facing materials, including the patient information sheet, to ensure that the use of NCRAS data was communicated clearly and accessibly.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NDRS Cancer Consolidated Data, NDRS Cancer Registration datasets to Queen Mary University of London.

The Data will not be transferred to any other location.

The Data will be stored in a Data Safe Haven (DSH) which is provided by ARO - a UK based cloud TRE provider.

Data will be backed up at a second data centre managed by ARO

Data will be accessed remotely by authorised personnel using organisation managed devices only.

- 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 DSA) and complies with the organisation’s remote access policy.

The Data will not be processed / accessed remotely outside of the UK at any time.

Access is restricted to employees or agents of Queen Mary University of London or University of Sheffield who have authorisation from the Principal Investigator

Access is restricted to employees or agents of ARO for administrative purposes only.

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

The Data will be linked at person record level with the YORKSURe study analysis dataset obtained from participant self-reported and clinical outcomes.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts from QMUL and University of Sheffield will process the Data for the purposes described above

Data on the population cancer registrations in the specified ICBs for the population will not be linked to any other datasets.

The expected outputs of the processing will be:

• The main trial findings will be summarised in reports and disseminated widely through multiple research outputs, including conference proceedings, presentations.

• Submissions to peer reviewed journals

• Presentations to QMUL and related HE organisations

• Presentations at appropriate conferences

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

• Social media - Research outputs may also be publicised through the social media accounts of collaborating organisations.

• Public reports

• Posters displayed at appropriate conferences

• Press/media engagement - Given the media interest throughout the study, it is anticipated that results will receive coverage in the media, further amplifying their reach.

• Reports aimed at participants

A publication will be written within 6 months following the receipt of the year 1 dissemination This publication will be due in May 2026, assuming the year 1 dissemination is available in November 2025. This publication will be report on the primary findings of the trial, including follow up data. Complete results from the follow-up phase will be disseminated in a publication within 6–12 months after the final year 3 data dissemination (between April 2029 – October 2029).

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 the subject matter of the study.

The use of the data could also:

• help the system to better understand the health and care needs of populations.

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

• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

While individual data will not be returned to participants, the findings from YORKSURe will indirectly benefit future patients. The data received will help assess the feasibility of a Phase III trial aimed at improving cancer diagnosis and outcomes. If feasible, this could lead to earlier detection, faster treatment and better survival rates. In the short term, the data may highlight gaps in care and inform service improvements, contributing to more effective, patient-centred cancer pathways.

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 specific patients.

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, these outputs will inform whether a large-scale Phase III trial is viable. If so, future research could provide robust evidence to inform national screening or diagnostic policies, improve early cancer detection and shape clinical guidelines.

Should the findings warrant wider attention, we will coordinate press releases and public engagement activities through the press offices of University of Sheffield, Queen Mary University of London, and our funder Yorkshire Cancer Research. Findings will also be disseminated via academic publications, conferences and engagement with relevant professional bodies and charities. We will work with our PPI members to ensure outputs are accessible and relevant to the public and people affected by cancer. Our PPI members also have established links to bladder cancer charities including Action Bladder Cancer UK, who would be well placed to help promote the study findings through their networks and communication channels, ensuring they reach a wider audience of patients, carers, and advocates.

Yielded Benefits is not a requirement for new applications.