Mortality data for OCCAMS cohort

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

Datasets: + Civil Registrations of Death

Objective for processing

Cancer of the stomach or oesophagus (gullet) or at the junction between the oesophagus and the stomach (Oesophageal and junctional adenocarcinomas (OAC)) have a poor prognosis and survival rate and in contrast to other cancers, knowledge of the molecular pathogenesis of the disease has not yet been used to determine prognosis and therapy. Cambridge University Hospitals NHS Foundation Trust and University of Cambridge requires access to further mortality data for the purpose of The Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) study. Cambridge University and the Cambridge University Hospitals NHS Foundation Trust require ONS mortality data for use in the Oesophageal cancer clinical and molecular stratification (OCCAMS) research study. The OCCAMS study is a network of clinical centres across the UK recruiting patients with oesophageal and gastro oesophageal junction adenocarcinoma. Oesophageal adenocarcinoma patient data and clinical samples are used to identify clinical demographic and molecular factors affecting development and progression of this cancer. OCCAMS is a large multisite observational study that has involved 26 NHS hospital trusts in the UK and it has been adopted on the National Institute for Health Research’s (NIHR) portfolio of high-quality studies. The study is funded by Cancer Research UK and has been running since 2010. It was instigated by Cambridge University in collaboration with Cambridge University Hospitals NHS Foundation Trust. OCCAMS is a large multisite observational study involving over 15 NHS hospital trusts in the UK and it has been adopted on the National Institute for Health Research’s portfolio of high-quality research studies. Recruitment to the study and data collection will be complete in 2020. The aims of the OCCAMS study are to: • Better characterise the clinico-demographic risk factors • Characterise the molecular genetic landscape (DNA, RNA, epigenome) • Determine disease sub-types and develop new clinically relevant classification systems • Develop and validate improved clinical staging and prognostic algorithms • Ascertain new therapeutic targets for future research Under this iteration of this Data Sharing Agreement (DSA), the University of Cambridge ask that PhD students at the University are permitted to process the requested data in support of the aims stated above. The study was instigated by the University of Cambridge (UoC) in collaboration with Cambridge University Hospitals NHS Foundation Trust (CUH). UoC and CUH are the joint Data Controllers and study sponsors, as they are both responsible for decisions determining how and why the data is used for this study. UoC and CUH are also Data Processors. NHS England data from this Agreement will be securely stored on servers owned by CUH. Processing and analysing of the study data are carried out solely by substantive employees of UoC within the CUH secure environment. The substantive employees of UoC also hold honorary contracts or Letters of Access with CUH. Other clinical centres act as recruiting sites and are not involved in the data processing. Cambridge University Hospitals NHS Foundation Trust (CUH) data backups are stored within CUH as well as with Amito, a secondary data centre. Amito, previously known as Everest Data Centre, provide backup storage to the CUH servers. Amito will not access the data held under this Agreement. 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 databases containing the data. Telefonica are outsourced infrastructure providers who manage CUH IT systems including backups. Telefonica are considered data processors as they supply support to the system, and have access to the backup data files in order to manage them. [2 paragraphs unchanged] • Better characterise the clinico-demographic risk factors; Characterise the molecular genetic landscape (DNA, RNA, epigenome); • Characterise the molecular genetic landscape (DNA (Deoxyribonucleic acid is a molecule that contains the biological instructions that make each species unique), RNA (Ribonucleic acid is a nucleic acid present in all living cells that has structural similarities to DNA), epigenome (the epigenome is a multitude of chemical compounds that can tell the genome what to do. The human genome is the complete assembly of DNA that makes each individual unique)); • Determine disease sub-types and develop new clinically relevant classification systems; • Develop and validate improved clinical staging and prognostic algorithms; • Ascertain new therapeutic targets for future research Mortality data is required in order to complete the clinical research records collected from the participating NHS hospital trusts. It gives a vital end point. Understanding how long a participant has lived with the disease and the particular nature of their condition will allow the research team to better understand the progression of the disease. With a poor prognosis, the patient group is likely to move into palliative pathway and die in the community including in hospices and at home. As such, the recording of death is less likely to be part of the original hospital record supplied by the participating hospital trusts. • Develop new clinically relevant classification systems; Full date of death is required as these patients' prognosis is measured in months. If only the month and year of death were provided, it would make survival data inaccurate (+/- 4 weeks is a very long period for these patients), rendering this dataset less valuable and rich for research purposes. This study aims to maximise specificity in order to achieve clear and robust outcomes. Where deaths are recorded in the hospital record, the study will have access to full date of death supplied by the NHS hospital trusts so receiving equivalent data from NHS Digital will enable consistency in analyses. One aim and potential benefit if successful is to understand how an individual’s genetic profile determines whether they will respond to particular treatment or which sub-category of cancer type (and prognosis) they fall in to. Understanding how long a participant has lived with the disease and the particular nature of their condition will allow the research team to better understand the progression of the disease, and achieve the above study aims. Patients are identified for inclusion in the study via Multidisciplinary Teams (MDTs) at each site. Inclusion criteria is any patient with a proven diagnosis of cancer at the junction between the oesophagus (gullet) and the stomach, including those undergoing surgery or non-surgical therapy. This includes recruitment of patients with early through to advanced stage disease. The NHS hospital Trusts identify and recruit eligible participants and provide details of the participants (including biological samples and person identifiable data) to the Cambridge University Hospitals NHS Foundation Trust. The samples are labelled with a unique patient ID, and UoC performs laboratory tests on the pseudonymised samples. The pseudonymised data linked to these samples can only be reidentified by the clinical team at CUH. There are currently approximately ~4600 study participants, and recruitment is due to continue until the end of 2026 at the rate of a maximum of 40 patients a year. To this end, identifiable mortality data (dates and causes of death) are required in order to complete the clinical research records collected from the participating NHS hospital trusts. It gives a vital end point. With a poor prognosis the patient group is likely to move into palliative pathway and die in the community including in hospices and at home. As such, the recording of death is less likely to be part of the original hospital record supplied by the participating hospital trusts. Date of death and cause(s) of death is required. Full date of death is required as these patients' prognoses are measured in months, as the nature of this disease means the time between diagnosis and death can be quite short. If only the month and year of death were provided, it would make survival data inaccurate (+/- 4 weeks is a very long period for these patients), rendering this dataset less valuable and rich for research purposes. It is essential the survival data is accurate to be usable. This study aims to maximise specificity in order to achieve clear and robust outcomes. Where deaths are recorded in the hospital record, the study will have access to full date of death supplied by the NHS hospital trusts so receiving equivalent data from NHS England will enable consistency in analyses. The cause(s) of death is required to know if the death is related to the disease or not, and therefore also essential to ensure survival data is accurate. The mortality data will provide additional intelligence to analyses already being undertaken. This data provides the outcome and indicates effectiveness of treatment each patient received. Informed consent has been given by the data subjects to use their personal data to collect and process the mortality data in this way, and the consent documents have been reviewed and approved by a Regional Ethics Committee. The current ethical approval expires in March 2026. Findings from the analyses of the mortality data will supplement existing data areas as well as allowing the study team to test further certain correlations between what is affecting prognosis and length of time that a participant is living with the disease and clinical and genomic characteristics of the individual. OCCAMS clinical trial is a single research project that will solely have access to data provided by NHS England. It is one of the largest cohort studies of its kind, and is invaluable for increasing/improving the knowledge base for oesophageal cancer. This project is not done in a vacuum, however: the OCCAMS research team have additional projects that will look at the end results of this work in the form of aggregate data with small numbers suppressed. No data provided by NHS England will be shared with other organisations. The study is funded by a grant from the Medical Research Council (MRC) awarded for the purposes of increasing knowledge of the processes and development of new clinical methods of treatment of oesophago-gastric cancer (expires in March 2026). MRC are not involved in any data processing, do not have access to the data and do not determine the means of purpose of the processing. There is a collaboration agreement between Genomics England, and the University of Cambridge/Cambridge University Hospitals NHS Trust (Cambridge). This was to allow Cambridge to make available to Genomics England material together with related anonymous data which are derived from a much smaller number of participants (250) from OCCAMS and another study, for the purpose of whole genome sequencing. It was also agreed by Cambridge to make available some identifiers to Genomics England relating to the materials, to enable Genomics England to hold the materials and the data for the purpose of undertaking the whole genome sequencing and making the resultant sequence data, together with the data from Cambridge (excluding identifiers) and other longitudinal data obtained by them from third parties, available for research to academic and commercial users, for use in its research environment. As such Genomics England are not considered to be data controllers or data processors in relation to the OCCAMS study or this Data Sharing Agreement. The number of years requested, and the geographical spread of the data requested is to ensure all participants of the OCCAMS study cohort are included in the dataset. Some sites are now closed to recruitment but committed to follow up data, and remaining recruitment sites are continuing until the end of the study in 2026. The outcomes of this study are hoped to continue to directly benefit patients by improving the understanding of this poorly understood disease to enable earlier detection and determination of the likely severity and rates of progression so that more appropriately personalised medicines and treatment plans can be prescribed. It is hoped this will also improve awareness for patients so they can better understand their pathway so that their own expectations and those of their families can be appropriately managed. The current knowledge base for this cancer type is particularly small and patients’ outcomes are often analysed on an aggregate level. This study will perform one of the first analyses of prognosis and mortality on a cohort of this size. The release of mortality data will enhance the existing efforts to fully categorise Oesophageal cancer and understand the different prognosis and pathway of patients with particular clinical and genomic characteristics. The analysis and publication of the findings are expected to pave the way for more effective strategies including earlier detection of cancer or more targeted, personalised treatment approaches providing benefits to individuals, health care services and society in general. In future, alternative cancer treatments and diagnostics will benefit from the increased knowledge base that the research team expect to develop through the survival data to allow further research teams to develop new treatment trials. One such treatment trial already linked in to OCCAMS is Neo-AEGIS, led by Southampton NHS Trust Clinical Trials unit which is trialling different approaches to chemotherapy in treatment. The findings of this study and associated clinical trials, which will include information on differentiating more aggressive cancers from less aggressive cancers as well as biomarkers for earlier detection will be widely disseminated on an international scale to maximise the impact and benefits to patients and patient care. The aim is also to feed into The National Institute for Health and Care Excellence (NICE) guidelines via publications, recommendations from key advisory bodies, and stakeholder consultations. The release of mortality data is hoped to enhance the existing efforts to fully categorise Oesophageal cancer and understand the different prognosis and pathway of patients with particular clinical and genomic characteristics. The mortality data hopes to be used to accurately calculate the period of disease progression, i.e. how long the participants have lived with the disease. Along with the particular nature of their condition this will allow the research team to better understand the progression of the disease. Data from this study is included in a PhD studying the epidemiological and molecular predictors of prognosis and survival. Data from this Agreement is key to the project, which is encompassed by the same purpose as the overall OCCAMS study. Any data processed as part of the PhD will be pseudonymised and when published will be aggregate data with small numbers suppressed. This is in line with the ethically approved, stated objective of OCCAMS which is to: Develop and validate improved clinical staging and prognostic algorithms. In order to analyse prognosis it is essential to have the survival data. The processing necessary to perform this task is in the public interest (Article 6 (1)(e)) as the results of this study will provide information for future therapeutic options with this specific condition. Future alternative cancer treatments and diagnostics will benefit from the increased knowledge base that the research team expect to develop through the dataset to allow further research teams to develop new treatment trials. Public interest is in line with Article 9 (2) (j) ‘processing is necessary for scientific or historical research purposes’. Processing these data is necessary for successfully fulfilling the aims of this study as listed above. In accordance with GDPR Article 89(1) processing is subject to appropriate safeguards. These include: ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS England's acceptance criteria (see sections 2 and 5b of this application for further details); iii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details); iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection (see sections 5a, 5b and 8a of this application for further details); v. Measures to protect the rights and freedoms of data subjects have been assessed including transparency (fair processing) publishing subject’s rights to withdraw consent and/or have their data erased or rectified, etc. (further information on fair processing is provided within this Abstract below and in section 4 of this application). The Cambridge PPI panel have contributed several times with the study design and document reviews. Between the period of 2017 till 2022 they have reviewed documents which include patient information sheets and consent form content and design of patient facing instruction leaflet for collection of blood samples using blood spot cards to ensure all are patient friendly. They also had input with design of a 13 page lifestyle and exposures questionnaire which provides valuable study data. Oxford University Hospitals NHS Foundation Trust whilst noted in some of the participant information sheets are no longer part of the study and will not process or have access to any of the data flowing from NHS England. Oxford University Hospitals NHS Foundation Trust have not had any access to any data disseminated under any previous versions of this agreement. No Cancer Data will be stored or processed at Cambridge University Hospitals NHS Foundation Trust or Telefonica Tech Northern Ireland Limited. Telefonica Tech is being added to the Mortality agreement as a data processor. Genomics England whilst noted in some of the participant information sheets and consent forms will not process or have access to any of the data flowing from NHS England. Genomics England have not had any access to any data disseminated under any previous versions of this agreement. Natera whilst noted in some of the participant information sheets and consent forms will not process or have access to any of the data flowing from NHS England. Natera have not had any access to any data disseminated under any previous versions of this agreement.

Processing activities

Data supplied by participating trusts Mortality data previously disseminated under this Agreement is currently held on CUH servers. The NHS hospital trusts identify and recruit eligible participants and provide details of the participants (including biological samples and person identifiable data) to the Cambridge University Hospitals NHS Foundation Trust. The samples are labelled with a unique patient ID, and Cambridge University performs laboratory tests on the anonymised samples. Flows of data into NHS England: NHS Digital data The OCCAMS study coordinator will provide NHS England with name, date of birth, NHS number, and the pseudonymised OCCAMS study ID for all participants who gave informed consent. Access and storage Flows of data out of NHS England: The Cambridge University Hospitals NHS Foundation Trust will provide to NHS Digital a list of participants’ identifiers (specifically name, sex, date of birth and NHS number plus unique OCCAMS ID). NHS England will match and flag the cohort and will return identifiable mortality data (including date and cause of death) linked to the study ID. This data will be stored on the CUH secure server, and analysed by substantive employees of UoC, who also hold honorary contracts or letters of access with CUH all of whom have been appropriately trained in data protection and confidentiality. NHS Digital will provide quarterly cohort event notification and Cause of Death reports (including date of death) for all deceased participants. This data will only be stored at the Cambridge University Hospitals NHS Foundation Trust. Cambridge University Hospitals NHS Foundation Trust data backups are stored within CUH as well as with Amito, a secondary data centre. Amito, previously known as Everest Data Centre, provide backup storage to the CUH servers. Amito will not access the data held under this Agreement. The date and cause of death data will only be accessed by individuals within the Upper GI trials office at the Cambridge University Hospitals NHS Foundation Trust who have authorisation from the Clinical Study Coordinator to access the data for the purpose(s) described, all of whom are substantive employees of the Cambridge University Hospitals NHS Foundation Trust or Cambridge University. Telefonica are outsourced infrastructure providers who manage CUH IT systems including backups. Telefonica are considered data processors as they supply support to the system, and have access to the backup data files in order to manage them. Processing The NHS England data will be stored on a restricted access network drive, with access restricted by password to the authorised user of the data only. Both the PC and the network drive are part of the CUH secure network. The local network and PCs are operated under the CUH information security and information governance policies. Mortality The mortality data will be pseudonymised when it is linked to data from the participating trusts, and those data derived from analysing the samples. All publications will use aggregated data, with small numbers suppressed. Once the Mortality data has been processed, it will then be pseudonymised, linked and analysed in conjunction with data acquired from the participating trusts and derived from analysing the samples. The mortality data will provide additional intelligence to analyses already being undertaken. This data provides the outcome and indicates effectiveness of treatment each patient received. Analysts at the Cambridge University Hospitals NHS Foundation Trust will have access [15 words unchanged] of birth and date of death, as well as cause of death. OCCAMS is an independent clinical trial , although it is expected that findings from OCCAMS trial will pave the way for future research in this area. These data will not be linked to publicly available data. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. The data will not be used for any purpose other than to meet objectives as stated in this Agreement and will not be shared with any third party organisation. Data will be pseudonymised and when published it will not be at the individual level, but in the form of aggregated outputs with small numbers suppressed. This will greatly reduce the chances of any participants being identifiable from any publications. The data flows differ between the 2 agreements In place for this study covering the mortality/ cancer data flows largely due to the technical arrangements which were in place with the different providing organisations. Now that data will all be provided by NHSE the applicant will look to consolidate this for future data flows. For this flow the data processing locations and arrangements will remain as historically agreed.

Expected output

The OCCAMS research team regularly publish findings relating to their studies about oesophageal cancer in high profile journals such as ‘Nature Genetics’ and the ‘British Medical Journal’. The most recent publication was a paper on ‘Mutational signatures in oesophageal adenocarcinoma define etiologically distinct subgroups with therapeutic relevance’ published in ‘Nature Genetics’ in September 2016. This paper proposed a framework to classify types of oesophageal cancer by genomic profile. To date, 5 papers have been published as a direct result of the study and over 20 from closely-linked research projects. The findings of this study and associated clinical trials, which hope to include information on differentiating more aggressive cancers from less aggressive cancers as well as biomarkers for earlier detection, aim to be widely disseminated on an international scale to maximise the impact and benefits to patients and patient care. The aim is also to feed into NICE guidelines via publications, recommendations from key advisory bodies, and stakeholder consultations. Findings from the analyses of the ONS data will supplement existing data areas as well as allowing the team to test further certain correlations between what is affecting prognosis and length of time that a participant is living with the disease and clinical and genomic characteristics of the individual. A mortality-related paper will be submitted to journals such as ‘Nature Genetics’ and the ‘British Medical Journal’. This is expected by December 2021. This is beyond the end date of the OCCAMS research project as there is necessarily some time needed between the last patient enrolled and the final processing being finished. Many of the OCCAMS study patients choose to consent to Clinical trials pre and post-surgery and receive chemotherapy that may not be routine standard care. The analysis of these patients’ research blood samples to measure levels of circulating tumour DNA and matched clinical data timepoints may be used in future to predict response to chemotherapy and influence choices for relevant trials. Please note that OCCAMS clinical trial is a single research project that will solely have access to data provided by NHS Digital. It is one of the largest cohort studies of its kind, and is invaluable for increasing/improving the knowledge base for oesophageal cancer. This project is not done in a vacuum, however: the OCCAMS research team have additional projects that will look at the end results of this work, but no data provided by NHS Digital will be shared with other studies. Any outputs from the OCCAMS trial will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. It is hoped that study data collected about patient progress and survival data and their genomic information may continue to be used in the future to identify those patients most likely to have a recurrence or respond better to certain treatments. Access to NHS England survival data is key to this progress. The OCCAMS dataset is being continually expanded as hospitals continue to enrol patients and submit findings. As more information is amassed, it enables re-examination of previous findings but also new depths of analysis. For example, increasing evidence makes it possible to identify groups of patients with common characteristics that can be studied. As a consequence, the exact subjects of future studies and publications is unknown from the outset. These are ongoing processes and are continually being investigated and improved to benefit patient outcomes and further develop personalised treatment. However, it is expected that papers will continue to be written and published and the study disseminates findings regularly through conferences presentations in the UK and internationally where experts in the field will meet to discuss the latest developments in classification of cancer through genomics and treatment/diagnosis innovations. The OCCAMS research team regularly publish findings relating to their studies about oesophageal cancer in high profile journals such as Nature Genetics and the British Medical Journal. No patient level data will be shared with any other party. 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 Since the previous version of this Agreement, several papers have been published including: Mutational signatures in esophageal adenocarcinoma define etiologically distinct subgroups with therapeutic relevance Maria Secrier et al Nat Genet 2016 Oct;48(10):1131-41. doi: 10.1038/ng.3659. Epub 2016 Sep 5. A comparative analysis of whole genome sequencing of esophageal adenocarcinoma pre- and post-chemotherapy. Noorani A, Bornschein J, Lynch AG, Secrier M, Achilleos A, Eldridge M, Bower L, Weaver JMJ, Crawte J, Ong CA, Shannon N, MacRae S, Grehan N, Nutzinger B, O'Donovan M, Hardwick R, Tavaré S, Fitzgerald RC; Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) Consortium. Genome Res. 2017 Oct;27(10):1782. doi: 10.1101/gr.229153.117 The landscape of selection in 551 esophageal adenocarcinomas defines genomic biomarkers for the clinic. Frankell AM, Jammula S, Li X, Contino G, Killcoyne S, Abbas S, Perner J, Bower L, Devonshire G, Ococks E, Grehan N, Mok J, O'Donovan M, MacRae S, Eldridge MD, Tavaré S; Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) Consortium, Fitzgerald RC. Nat Genet. 2019 Mar;51(3):506-516. doi: 10.1038/s41588-018-0331-5. Epub 2019 Feb 4. Longitudinal sampling of 97 Oesophageal adenocarcinoma using liquid biopsy sampling Ococks E, Frankell AM, Masque Soler N, Grehan N, Northrop A, Coles H, Redmond AM, Devonshire G, Weaver JMJ, Hughes C, Lehovsky K, Blasko A, Nutzinger B; OCCAMS Consortium, Fitzgerald RC, Smyth E. Ann Oncol. 2021 Apr;32(4):522-532. Serial ctDNA detection using a personalized, tumor-informed assay in esophageal adenocarcinoma patients following resection Ococks E, Sharma S, Ng AW, Aleshin A, Fitzgerald RC, Smyth E; OCCAMS Consortium. Gastroenterology. 2021 Jul 17:S0016-5085(21)03245-5. doi: 10.1053/j.gastro.2021.07.011. Epub ahead of print. PMID: 34284036. https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/bespoke-circulating-tumor-dna-assay-for-the-detection-of-minimal-residual-disease-in-esophageal-adenocarcinoma-patients https://www.icgc-argo.org/page/142/18th-icgc-scientific-workshop [4 paragraphs unchanged] The outcomes of the OCCAMS clinical trial will be used in corroborating findings and showing evidence of the benefits of new treatment pathways and early detection to evidence best practice; this will be shared directly with NICE. (No patient-level data will be shared with any other party, solely research result and generic findings.) The ultimate aim is to influence the NICE guidelines which determine best practice for GPs and doctors via publications, recommendations from key advisory bodies, and stakeholder consultations. These areas of work are ongoing and are being continually improved upon throughout the life of the study. Recruitment and data collection is expected to continue until 2020 and numerous outputs, in line with those described above, are expected over the course of the study. The outcomes of the OCCAMS clinical trial hopes to be used in corroborating findings and showing evidence of the benefits of new treatment pathways and early detection to evidence best practice; this aims to be shared directly with NICE. (No patient level data will be shared with any other party, solely aggregate data with small numbers suppressed.) The ultimate aim is to influence the NICE guidelines which determine best practice for GPs and doctors via publications, recommendations from key advisory bodies, and stakeholder consultations. Findings It is hoped that findings will be fed back directly to collaborating hospitals. As is common in research, depending on findings, there may be appropriate media attention to this work. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. The study has its own website where any news about the study is updated https://www.occams.org.uk/index.html Recruitment and data collection is expected to continue until 2026 and numerous outputs, in line with those described above, are expected over the course of the study.

Expected measurable benefits

The outcomes of this study are expected to directly benefit patients by [22 words unchanged] that more appropriately personalised medicines and treatment plans can be prescribed. This will could also improve awareness for patients so they can better understand their pathway so that their own expectations and those of their families can be appropriately managed. The current knowledge base for this cancer type is particularly small and patients’ outcomes not often analysed on an aggregate level. This study will may perform one of the first analyses of prognosis and mortality on a cohort of this size. The release of mortality data will may enhance the existing efforts to fully categorise Oesophageal cancer and understand the different prognosis and pathway of patients with particular clinical and genomic characteristics. One aim and potential benefit benefit, if successful successful, is to understand how an individual’s genetic profile determines whether they will be respond to particular treatment or which sub-category of cancer type (and prognosis) they fall in to. The analysis and publication of the findings are expected to pave the way for more effective strategies including earlier detection of cancer or more targeted, personalised treatment approaches providing benefits to individuals, health care services and society in general. In future, alternative cancer treatments and diagnostics will benefit from the increased knowledge base that the research team expect to develop through the ONS dataset to allow further research teams to develop new treatment trials. One such treatment trial already linked in to OCCAMS is Neo-AEGIS, led by Plymouth which is trialling different approaches to chemotherapy in treatment. The findings of this study and associated clinical trials, which may include information on differentiating more aggressive cancers from less aggressive cancers as well as biomarkers for earlier detection could be widely disseminated on an international scale to maximise the impact and benefits to patients and patient care. The aim is also to feed into NICE guidelines via publications, recommendations from key advisory bodies, and stakeholder consultations. The findings of this study and associated clinical trials, which will include information on differentiating more aggressive cancers from less aggressive cancers as well as biomarkers for earlier detection will be widely disseminated on an international scale to maximise the impact and benefits to patients and patient care. The aim is also to feed into NICE guidelines via publications, recommendations from key advisory bodies, and stakeholder consultations. It is hoped these data serve to provide the research community with the opportunity to build on findings/ outcomes from the OCCAMS project. This in turn provides more information and knowledge about treatments, outcomes, disease progression, and may benefit future patients through personalised treatment. OCCAMS additionally convey information to current patients in follow up, meeting up with patients regularly at clinics and giving feedback about study progress and recruitment. This keeps the patients motivated and also lets them know how valuable their contribution is. New patients are also very keen to know details of how current samples and data are progressing the study towards improving knowledge and treatment options and developing new trials. At no point in this process would specific information about another patient be given to anyone else, and no information from NHS Digital be shared with anyone else. NHS England data would not be shared with associated clinical trials or any other third party, except in aggregate form with small numbers suppressed in line with the HES analysis guide. NHS Digital data will not be shared with associated clinical trials or any other third party, except in aggregate form with small numbers suppressed. The annual OCCAMS symposium is attended by approximately 60-80 investigators from the UK and overseas. Members of the OCCAMS consortium present their data from projects which accessed OCCAMS samples and data This study has been adopted to the NIHR portfolio. The NIHR portfolio consists of clinical research studies that are eligible for support from the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) in England. All high-quality research studies, eligible for NIHR CRN support in England, are included on the NIHR CRN Portfolio. For a study to be eligible to be adopted to the NIHR portfolio, it must satisfy the requirements of the Department of Health and Social Care established Eligibility Criteria (https://www.nihr.ac.uk/documents/researchers/collaborations-services-and-support-for-your-research/run-your-study/Eligibility%20Criteria%20for%20NIHR%20Clinical%20Research%20Network%20Support.pdf)

Benefits reported

N/A The OCCAMS study conveys information to current patients in follow up, meeting up with patients regularly at clinics and giving feedback about study progress and recruitment. A yielded benefit of OCCAMS is allowing patients to have a better understanding of their disease. This keeps the patients motivated and also lets them know how valuable their contribution is. New patients are also very keen to know details of how current samples and data are progressing the study towards improving knowledge and treatment options and developing new trials. At no point in this process would specific information about another patient be given to anyone else, and no information from NHS England be shared with anyone else. The findings from the OCCAMS study has already led to the establishment of a revised Output Area Classification (OAC) classification method (https://pubmed.ncbi.nlm.nih.gov/19526624/) This revised classification based on number and location of involved lymph nodes provides improved prognostic power and incorporates features that may be useful before surgery in clinical management decisions. This allows for provision of more accurate tumour staging and prognosis information to be available for patients so that they may be better informed about future possible treatments and their prognosis. The study has led to multiple publications. Papers continue to be written and published and the study disseminates findings regularly through conferences, presentations in the UK and internationally where experts in the field meet to discuss the latest developments in classification of cancer through genomics and treatment/diagnosis innovations. Publications, listed in the outputs section, focussing on treatment outcomes and detection and analysis of ctDNA (circulating tumour DNA) collections in detecting disease recurrence showed that ctDNA levels post-surgery could act as a predictor for patient relapse and assessment of treatment response following chemotherapy. The data available and the publications were enhanced by the extensive clinical data available.