NHS Digital Data Release Register - reformatted

Institute Of Cancer Research projects

417 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Institute Of Cancer Research was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Institute Of Cancer Research may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

A National Study Of Breast Cancer And A Range Of Late Effects Of Hodgkin Lymphoma Treatments In Women (ODR1516_470) — DARS-NIC-659282-H1F7C

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2022-11-17 — 2023-11-16

Access method: One-Off

Data-controller type: THE ROYAL MARSDEN NHS FOUNDATION TRUST, THE INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registry
  2. NDRS Linked HES A&E
  3. NDRS Linked HES APC
  4. NDRS Linked HES Outpatient
  5. NDRS Cancer Registrations
  6. NDRS Linked HES AE

Objectives:

This study has historically been managed by the Institute of Cancer Research (ICR), however following the retirement of the study’s Principal Investigator (PI) a new PI was selected from the Royal Marsden NHS Foundation Trust (RMNFT). This request is to add the RMNFT as a Data Controller and Data Processor to reflect that the purposes and means of processing will now be determined by, and processed by, individuals substantively employed by the RMNFT.

The ICR will remain as a controller and processor, as it is they who will be responsible for deciding how the data currently held at the ICR will be securely transferred to the RMNFT. Once all data held at the ICR has been transferred to the RMNFT, the ICR should no longer be considered a data controller or processor and will provide NHS Digital with evidence of data destruction. The RMNFT should take the appropriate steps to amend this Agreement to remove the ICR from this Agreement.

The principal aim of this study is to improve understanding of the risks of the wide range of long-term fatal and non-fatal morbidities in women treated for Hodgkin Lymphoma (HL) at young ages, and to create a unique risk profile of incidence and severity of multiple long-term comorbidities, in order to enable clinicians and patients to understand patients’ personalised risk profile when deciding on and consenting for treatment, and when managing follow-up and screening for late-effects.

Secondary aims are:
1. To determine the risks of developing second cancers, other morbidity, and cause-specific mortality in relation to newer HL treatment modalities, e.g. Doxorubicin (Adriamycin), Bleomycin, Vinblastine and Dacarbazine (ABVD) chemotherapy, which have been developed over the last 15-20 years with the aim of reducing the risk of long term toxicity, and compare these with older regimens such as Mechlorethamine, Vincristine (Oncovin), Procarbazine and Prednisone (MOPP) to clarify the extent to which late effects are attenuated by the more modern treatments.
2. To extend the range of morbidities for which data are available on adverse treatment effects from older HL treatments. Although there is considerable information on the effects on cancer and cardiovascular disease in the first 25 years after treatment, there is little for many other effects and for longer periods. This is important since a wide range of body systems are damaged by HL treatment, and since HL patients are largely treated as children or young adults, effects 40 and 50 years later are still of great importance – for instance, does breast cancer risk in these women remain raised, and therefore should intensive breast screening continue, or cease, at older ages?

To support these aims the study team request permission to retain the following datasets that were previously disseminated by the Public Health England (PHE) National Cancer Registration and Analysis Service (NCRAS):
• Identifiable National Disease Registry Service (NDRS) Cancer Registration Data
• Identifiable NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Outpatient, Admitted Patient Care and Accident & Emergency subsets.

The ICR is permitted to retain this data until all the data has been successfully transferred to RMNFT, after which the ICR must destroy all data relating to this Agreement. RMNFT are permitted to retain and process data until the end date of this Agreement.

To address the UK GDPR principle of minimisation the data disseminated has been minimised to a cohort of ~10,000 women who were treated for HL at ages <35 years during 1956-2010. Further to this, prior to dissemination, the study team had extensive conversations with the NCRAS analysts who were able to assist the study team in ensuring that the request is limited to the minimum amount of data necessary for achieving the purposes outlined within this DSA.

The lawful basis for this processing falls under the UK General Data Protection Regulation (GDPR) Article 6(1)(e), the processing is necessary for the performance of a task in the public interest. The study processes sensitive health information for the purposes of scientific research with appropriate safeguards in place to protect personal information. The processing of special category data falls under UK GDPR Article 9(2)(j), the processing is necessary for scientific research, 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). The data are required for research purposes in the public interest - meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data.

This project has received funding from the National Institute of Health Research (NIHR), beyond providing funds for the study the NIHR does not play a role in determining the purpose and means of processing and does not process data disseminated under this Agreement.

Yielded Benefits:

The aim of this study is to enable patients and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term effects of a range of cancer treatments and therefore understand risks better, achieve greater informed consent at the point of cancer treatment, and embark on a more personalised care pathway. Such information would form a vital component of patients’ long-term “survivorship plans”, which are integrated into the NHS as a key part of patient care. Specific benefits that have arisen since this support has been in place: 1. The setup of this study and initial results enabled the publication of detailed risk profiles of these women’s much higher long-term risk of developing breast cancer following their Lymphoma treatment. In large part as a result of the information provided from this study, a national high-risk breast cancer screening programme (in partnership with PHE - now NHS Digital - and the Christie) has been established – BARD – breast screening after radiotherapy dataset. This is facilitating the systematic invitation of women to have breast cancer screening identified as being at high risk of developing breast cancer from the cancer treatments they received, as a direct consequence of the results of this study. It is hoped that this screening will significantly mitigate the risk of breast cancer in these women and enable earlier diagnosis and treatment to improve their long-term survival.

Expected Benefits:

This study aims to better understand the health impacts of HL treatment in women who were treated for HL <35 years, with a focus on whether certain HL treatments are associated with a greater incidence of second cancers and whether certain HL treatments are linked with negative future health outcomes. Carrying out this research may develop a greater understanding of the risks and benefits associated with HL treatments.

If the study findings are incorporated into clinical guidelines, the study may contribute to improved health outcomes for individuals that receive treatment for HL.

Outputs:

It is anticipated that the study findings will be published in peer-reviewed journals and will also be presented at relevant conferences.

Should the opportunity arise, the study may publish findings on the Trusts webpages, hold open lectures or engage with the press, this will aid the dissemination of the findings and will reach interested groups in civil society.

The study team are also required to provide NIHR, the study funder, with a final report that outlines the study's findings.

Bone Marrow Micrometeseses In Primary Breast Cancer – MR500 — DARS-NIC-291953-M8M9V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Anonymised - ICO Code Compliant (, )

Legal basis:

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2011-12-02 — 2026-12-02

Access method: Ongoing

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Flagging Current Status Report
  3. MRIS - Members and Postings Report
  4. MRIS - Personal Demographics Service

Objectives:

Identification of women who are at high risk of relapse after complete excision of the primary breast cancer. The presence of micormetastases may be assosicated with prognostic factors such as lymph node involvement and large tumour size and also with early disease recurrence.
Attempts to follow-up via original centres became problematic as the time from diagnosis increases and patients are discharged from routine follow-up. ICR use the requested data to link with trial data reported on CRFs to allow survival analyses to be conducted.
The aim of the Micormetastases study was to investigate the relationship between the presence of micrometastases at the time of diagnosis on long-term relapse-free and overall survival, and to determine whether this is an independent prognostic factor or related to other factors such as lymph node involvement and large tumour size

Yielded Benefits:

Outputs:

Main results from the study and results of median long term follow-up effects have already been published (Br Med J, (6606): 1093-1096; Lancet, 354:197-202).
Analysis is ongoing with the aim of submitting for publication in peer-reviewed journals. Patients will not be identifiable and tables will be aggregated by randomised treatment group. Cells within aggregates will not allow identification of individual information.

Processing:

The cohort is already flagged at the HSCIC and ICR continue to require information on deaths and exits from the system. Death notifications should include date of death and cause of death.
Standard statistical methods for survival analysis will be used to investigate overall and relapse free survival, including (but not limited to) Kaplan-Meier plots, logrank tests and Cox PH Models.

MR1251 - Safety and appropriateness of growth hormone treatments in Europe (SAGHE) — DARS-NIC-148155-K7P19

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2020-01-01 — 2020-10-31

Access method: One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Flagging Current Status Report

Objectives:

This Data Sharing Agreement permits the Institute of Cancer Research to retain and process data which has been supplied by NHS Digital (and predecessor organisations) for the purpose of a research study referred to Safety and appropriateness of growth hormone treatments in Europe (SAGhE).

Growth hormone treatment has been used since 1957 to treat growth hormone deficiency, and thereafter increasingly for short stature due to other causes. Initially hormone extracted from human pituitaries (p-hGH) was used, and then since the mid 1980s synthetic recombinant human GH (r-hGH). Concerns about long-term safety were initially caused by an outbreak of Creutzfeldt-Jakob disease consequent on prion infection of pooled pituitaries used to produce human GH, whose use was therefore discontinued in 1985. Subsequently concerns were raised by reports of apparent excesses of leukaemia and other cancers, and more recently of mortality in France although not in three other countries. There have been a number of studies investigating cancer and mortality risks in such patients. Raised risks of death and certain cancers have been reported inconsistently, but these findings have limitations and leave considerable uncertainty.

The SAGhE (Safety and Appropriateness of Growth Hormone Treatments in Europe) study was therefore initiated, funded by the EU, to provide a large-scale international collaborative cohort study of r-hGH treated patients with long-term follow-up for cancer incidence and mortality conducted independently of pharmaceutical companies. It is the largest and longest follow-up cohort study of growth hormone-treated patients with follow-up and analysis independent of industry and has formed a major international resource for investigating cancer and mortality risks in r-hGH patients.

The study is of cohort design, conducted in 8 European countries, with the design and conduct coordinated from the outset and analyses centralised at ICR, (hence all data for the cohort analyses are sent to ICR). With appropriate ethics and privacy committee approvals, the study identified in each country all resident patients who were born before 1991-1995 (the exact year depending on the country), who had been treated with r-hGH at paediatric endocrine clinics at any time since first use of the treatment in 1984 up to a date during 2007-9, depending on the country (or in France and Sweden up to 1997), and who had never been treated with human p-hGH and followed them for cause-specific mortality and cancer incidence.

The cohort consists of 24,232 patients, most commonly treated for isolated growth failure (53%), Turner syndrome (13%) and growth hormone deficiency linked to neoplasia (12%). Data were extracted from existing databases and from case-notes on demographic variables, parental heights, birth characteristics, results of growth hormone testing and additional endocrine deficiencies, and treatment of those deficiencies, at regular intervals height, weight, pubertal status, bone age, growth hormone dose and number of weekly injections and associated treatments that might interfere with growth (sex steroids, GnRH agonists, steroids), the use of cranial or total body irradiation, the diagnosis for which r-hGH was prescribed.

Follow-up of cohort members for incident cancers, death, emigrations, and other losses to follow-up was conducted by various methods depending on the country. In the UK it was via NHS Digital. Reported cancer diagnoses were validated by cancer registry data or from pathology reports. National cause-specific mortality data and population counts for the general population, to derive ‘expectations’ for mortality rates in the cohort, were obtained from death certificate-based statistics from national statistics offices. National site-specific cancer incidence data, likewise, were obtained from national cancer registries (the Netherlands, Sweden, UK, and Belgium from 2004 onwards) or where national cancer registration did not exist, from national estimates based on regional registry data (Belgium before 2004, France, Germany, and Switzerland).

The study’s Principal Investigator is an individual employed by University College London Hospitals NHS Foundation Trust (UCLH) who has a honorary contract with University College London (UCL). However, under this Agreement no individual at UCLH or UCL is permitted to exercise any influence over the purposes for which the data may be processed.

The purposes for which the data may be processed are as follows:

Confidential identifying details may be securely retained and not otherwise processed in anyway.

Data related to cancer incidence may be securely retained and not otherwise processed in anyway.

Pseudonymised record level patient data relating to mortality from which the identifying details have been separated may be securely stored and processed as required to support:
i) Finalising a paper about mortality across the 8 countries, including conducting any further analyses that may be requested by the journal ahead of its publication;
ii) Responding to questions, challenges, etc. to the content of the paper post-publication.

No other processing of the data are permitted.

Under no circumstances may data be shared with or otherwise accessed by individuals employed by UCLH or UCL.

In accordance with the above stipulations, data may only be processed by individuals employed by the Institute of Cancer Research (ICR).

The ICR will be responsible for ensuring compliance with the above restrictions on processing and, as such, is the data controller for the purpose of this Agreement.

Processing the data as described will enable completion of publication of the results of this 8 country study. 3 papers are already published and the fourth is submitted.

The ICR has identified GDPR Articles 6(1)(e) (“a public task”) and 9(2)(j) (“research”) as the lawful basis for processing personal data for the purpose of this study. The ICR has determined that the processing is in the public interest for the safety and reassurance of patients treated with Growth hormone (GH) and their parents, relatives, and for the public to be reassured on whether children so-treated are being treated safely.

Yielded Benefits:

Expected Benefits:

The benefits to patients, clinicians and the public are that the published findings contribute to the safety and reassurance of patients treated with Growth hormone (GH) and their parents, relatives, and for the public to be reassured on whether children so-treated are being treated safely.

The papers published to date have raised awareness of the following findings:

- Having examined the cancer risks in relation to growth hormone (GH) treatment, the results did not generally support a carcinogenic effect of r-hGH but it was highlighted that the unexplained trend in cancer mortality risk in relation to GH dose in patients with previous cancer, and the indication of possible effects on bone cancer, bladder cancer, and HL risks, need further investigation.

- Having examined meningioma risks in relation to GH treatment, the findings added to evidence of very high risk of meningioma in patients treated in childhood with GH after cranial radiotherapy but suggested that GH may not affect radiotherapy-related risk and that there is no material raised risk of meningioma in GH-treated patients who did not receive radiotherapy.

Outputs:

Under the previous iteration of this agreement, 3 papers have already been published (Swerdlow, Cooke et al. 2015, Swerdlow, Cooke et al. 2017, Swerdlow, Cooke et al. 2019) and a fourth was submitted to The New England Journal of Medicine (NEJM) for review and acceptance. The NEJM declined to publish the paper.

The paper is now in the process of being reformatted for the Lancet with a view to send to the collaborators for their agreement in the coming weeks. Submission to the journal in planned by the end of January 2020, and if the journal are interested there may be one or more rounds of iteration with them over a 2-5 month period. If, however, they reject it at the first submission the ICR will submit to another journal, probably The Lancet Diabetes & Endocrinology, within a month of hearing back from them. If again rejected, new submission will probably be to the Journal of Clinical Endocrinology and Metabolism (JCEM), within a further month.

Subsequent to journal acceptance, the ICR will need to await publication, at a pace chosen by the journal, and then the data will be needed as noted in 5a (ii) to respond to any questions, challenges, etc. to the content of the paper post-publication. This will take several months, since publication does not happen immediately after acceptance, and responses from readers usually come 1-2 months after publication. In total, therefore, the ICR would estimate that 10 months is needed, in case submission has to be to more than one journal, followed by eventual publication and reader responses.

If necessary, further processing of the data may result in answering any questions raised by reviewers and journal editors in the review process, in order to obtain publication.

There may be subsequent presentations to meetings or conferences following publication of the data.

The published findings and any subsequent presentations will contain only data which is aggregated with any small numbers suppressed in compliance with NHS Digital’s published guidance and will contain no individual’s data.

Processing:

Identifiable data was shared with Health and Social Care Information Centre (HSCIC) to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with HSCIC. HSCIC notified the study team at the Institute of Cancer Research of participants’ deaths (date and cause) and cancer events when they occurred. Data was last supplied in March 2016.

There will be no new data flows under this Agreement. The data will be stored at the Institute of Cancer Research (ICR) and will only be accessed by individuals substantively employed by the ICR.

The identifying details and records relating to cancer incidence will be securely stored and not otherwise processed.

Pseudonymised records relating to mortality will be securely stored and only processed if new analyses are requested by the journal to which the final paper was submitted. In this case, the analyses will be conducted solely at ICR with no data flows or linkages and solely using data already held by the ICR.

Data processing will only be carried out by substantive employees of the ICR who have been appropriately trained in data protection and confidentiality.

MR1069 - BREAKTHROUGH GENERATIONS study — DARS-NIC-148096-PT589

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 - s261(5)(c)

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2018-08-01 — 2021-07-31 2017.06 — 2024.02.

Access method: Ongoing, One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. Cancer Registration Data
  7. Civil Registration - Deaths
  8. Demographics
  9. Civil Registrations of Death

Objectives:

The data supplied by the NHS IC to Institute of Cancer Research will be used only for the approved Medical Research Project - Breakthrough Generations Study.

Yielded Benefits:

The study is one of the major cohort studies worldwide focussed on cancer, and has produced over 100 scientific peer-reviewed publications (see section 5.c), many of them heavily used and cited (thousands of citations). These include contributions to discovery of the majority of the single nucleotide polymorphisms (SNPs) that are known to affect the risk of breast cancer, and many affecting risks of endometrial cancer, ovarian cancer and melanoma. These are the major discoveries in cancer genetics of the last 5-10 years that enable improved risk prediction and counselling for patients in clinics and their families. The ICR has published data showing that the previous literature has generally underestimated the risks of breast cancer from hormone replacement therapy (HRT), used by very large numbers of women around the menopause: this is vital in giving more accurate estimation of risks for patients and their doctors weighing the risks and benefits of taking HRT – a major public health issue. The ICR has developed, using the study data, a new, improved measure of family history of breast cancer incidence, to enable improved advice to women in clinics about their risk of breast cancer if members of their close family have had the disease, with greater precision and power than previously used measures. These outputs and uses demonstrate clearly the feasibility and public benefit.

Expected Benefits:

Finding the causes of cancer is important to enabling its prevention and identifying high risk groups for screening and early detection. Cancer now accounts for 26% of deaths in women in England, so is a major public health problem. Breast cancer is the most common cancer in women in the UK and worldwide. The Generations Cohort study was set up in 2003, to investigate the causes of breast cancer with exceptional focus, size and comprehensiveness, and also to investigate the causes of other cancers and causes of death in women.

Epidemiological evidence indicates that the aetiology of breast cancer involves genetic, behavioural and environmental factors, probably with interactions between these, and that the behavioural/environmental factors act at several different stages of life, probably starting before birth, and continuing to the menopause and beyond. Many of the likely causal factors are complex ones that are difficult or impossible to measure in retrospect – for instance serum concentrations of hormones at various ages – but more accurate investigation of these is crucial to understanding the causes of this cancer and hence its prevention.

To investigate these factors optimally needs a study in which information about them, and how they change through life, is collected prospectively in a large cohort of women, with long term follow-up for breast cancer. For aspects such as the relationship of serum concentrations of IGF1 and of sex hormones to risk of subsequent breast cancer, this is essentially the only design that can give valid data. Such a study design is also the optimal one to assess gene-environment interactions affecting the risk of breast cancer. The cohort design has similar strengths for investigation of other major cancers and causes of death.

The Generations cohort is one of the largest and most comprehensive in the world to investigate the causes of breast cancer, and provide risk prediction data to enable personalised screening and prophylaxis. It is also investigating breast cancer and ovarian cancer pathology and survival.

The study has exceptional detail, size and power to provide new information on the causes and genetics of breast cancer and other major diseases of women in the UK. The objective is to enable preventive measures for these diseases and to give information for patients and their families, doctors and other health professionals advising patients, the public, and policy makers, and for health promotion campaigns, on risk factors for these diseases and potential measures to reduce the risks, including targeted measures based on genetic and other factors. The study is also providing new data for personalised risk prediction, and on pathology and survival from cancer to aid diagnosis and treatment/ follow-up.

Outputs:

The planned outputs will include several hundred published papers in peer-reviewed scientific journals, submitted over the next 40 years, on the causes and risks of cancer incidence and cause-specific mortality, and on cancer pathology and survival, in women (see below for examples). The research is funded primarily by Breast Cancer Now, as the major part of a programme of breast cancer-related peer-reviewed research funded by them, and has produced many high-profile publications listed below, so PHE can be assured that it will continue to do so with longer follow-up and hence more valuable results. The extended follow-up will enable analyses on a growing spectrum of less-common conditions as greater numbers of cancers and deaths accumulate, and enable increasingly long-term risks to be assessed. The ICR will publicise the results to patients and society more widely by press releases and blogs, to professional standard, from the Institute’s and Breast Cancer Now’s very active communications departments, information sent to Breast Cancer Now (the major UK breast cancer charity) supporters and patient groups and put on the Study website, and by talks given to patient and lay groups as well as to appropriate medical and scientific conferences, meetings and seminars.

The study has now produced >100 papers in peer-reviewed journals, many in the leading research journals for their specialities, on aetiology and genetics and hence prevention and patient counselling of cancer and its risk factors.

Over the next 40 years the study is expected to produce several hundred more papers in peer reviewed journals, on aetiology and genetics, and hence patient counselling, on cancer and its risk factors and on other diseases. It is planned that during 2019 papers will be published on, among other topics, the relation of breast cancer risk to weight change (important for preventive messages on losing weight); the relation of breast cancer risk to shift work (an important public health issue given the large number of female shift workers and whether their shift work is affecting their cancer risk); breast cancer risks in relation to recent pregnancies (important because these temporarily raise risk, but it needs to be discovered how much and for how long after the pregnancy) and several papers on the genetic risks of female reproductive related cancer risks (important to genetic counselling of patients and their families).

Processing:

The study is of cohort design, recruiting volunteer women from the general population of the UK aged 18 years and older, who have completed an extensive questionnaire about breast cancer risk factors, given a blood sample, and given informed consent for follow-up via national routine data systems. Over 110,000 women have been recruited since 2003 with active recruitment stopping in 2009. Participants still continue to join the study, however these are not in great numbers. A cohort study is methodologically the most rigorous study design that can be undertaken of long-term cancer and mortality risks. Follow-up is primarily by 3-yearly questionnaires. It is planned that collection of exposure and follow-up data will continue for at least 40 years. In addition periodic newsletters are sent to participants with a reply slip for notification of changes in address and, with signed informed consent, the ICR also uses flagging at NHS Digital to provide follow-up data, including cancer registrations and causes of death.

The ICR supplies cohort identifiers to NHS Digital and the participants’ entries are then flagged on NHS Digital’s computer system. Only identifiers of participants with whom the ICR has lost contact or who have self-reported cancers and/or who are believed to have died are supplied to NHS Digital for flagging. Otherwise, the ICR continues to collect information directly from the participants. 41,695 participants had been flagged prior to September 2018. Approximately 800 additional participants who meet the above criteria will be flagged at fixed points each year. ICR will supply identifying details of these additional participants to NHS Digital for the purpose of flagging. Under this Agreement, the ICR is not permitted to flag new participants recruited during or since 2015 (at which point guidance NHS Digital issued new guidance on consent).

For flagged participants NHS Digital reports details of the cancer diagnoses and/or the details of deaths (date and cause) and also reports exits from registration with the NHS (e.g. if a participant emigrates). NHS Digital has supplied this data to the ICR on a regular basis over many years. These data are used only for analyses for the approved medical research project identified above.

Analyses are conducted of risk factors for breast cancer and other cancers and causes of death mainly by standard cohort analyses methods (Breslow & Day, 1987), but also in nested case-control analyses for exposure variables (e.g. various assays) that can only practically be obtained on this basis.

Identifiable data are required to ensure accurate linkages of individual participants’ data. Access to the identifiable data is restricted to ICR researchers with authorisation from the Chief Investigator, who is the Head of the ICR’s Epidemiology Team. The data will be accessed and analysed solely at ICR for the analyses described above, which are the purpose of the study and the purpose of obtaining the data from NHS Digital.

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 the data).

MR465 - National Cohort study of mortality and cancer incidence in patients with cytogenetic and paediatric endocrine disorders — DARS-NIC-147749-3SSRF

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Y, Identifiable, Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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(7), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2018-11-26 — 2020-02-06 2020.02 — 2020.10.

Access method: One-Off, Ongoing

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. Cancer Registration Data
  4. Demographics
  5. Civil Registration - Deaths
  6. MRIS - Members and Postings Report
  7. MRIS - Scottish NHS / Registration
  8. MRIS - Flagging Current Status Report
  9. Civil Registrations of Death

Objectives:

The data supplied by the NHS IC to Institute of Cancer Research will be used only for the approved Medical Research Project identified above.

Yielded Benefits:

Previous outputs from this study have been widely used for and by the relevant patients, as evidenced by the unusually high citation rates of the papers (in square brackets below): Swerdlow et al., Cancer incidence and mortality in men with Klinefelter syndrome: a cohort study. J Natl Cancer Inst. 2005;97:1204-10 [215 citations], Swerdlow et al., Mortality in patients with Klinefelter’s syndrome in Britain: a cohort study. J Clin Endocrinol Metab 2005; 90:6516-22 [160 citations], Schoemaker et al., Mortality in women with Turner syndrome in Great Britain: a national cohort study. J Clin Endocrinol Metab. 2008;93:4735-42 [160 citations], Schoemaker et al., Cancer incidence in women with Turner syndrome in Great Britain: a national cohort study. Lancet Oncol. 2008;9:239-46 [112 citations], Swerdlow et al., Mortality and cancer incidence in persons with numerical sex chromosome abnormalities: a cohort study. Ann Hum Genet 2001; 65:177-88 [169 citations], Hermon et al., Mortality and cancer incidence in persons with Down’s syndrome, their parents and siblings. Ann Hum Genet 2001; 65:167-76 [55 citations], Higgins et al. Mortality and cancer incidence in males with Y polysomy in Britain: a cohort study. Hum Genet 2007; 121:691-6 [21 citations], Swerdlow et al., Mortality risks in patients with constitutional autosomal chromosome deletions in Britain: a cohort study. Hum Genet 2008; 123;215-24 [7 citations], Swerdlow et al., Cancer risk in patients with chromosome deletions: a nationwide British cohort study. Br J Cancer 2008; 98:1929-33 9 [11 citations], Swerdlow et al., Mortality and cancer incidence in women with extra X chromosomes: a cohort study in Britain. Hum Genet 2005; 118:255-60 [17 citations], Swerdlow et al., Mortality in patients with congenital adrenal hyperplasia: a cohort study. J Pediatr 1998; 133:516-20 [62 citations]. Further evidence is the use for these studies in constructing and assessing clinical practice guidelines (e.g. Gravholt et al., Clinical practice guidelines for the care of girls and women with Turner Syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting. Eur J Endocrinol 2017;117:G1-G70. Leblicq et al., Are guidelines for glucocorticoid coverage in adrenal insufficiency currently followed? J Pediatr 2011; 158:492-498. Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V. Onkopedia Guidelines. Klinefelter Syndrome and Cancer. DGHO; Berlin, Recommendations from the society for diagnosis and therapy of haematological and oncological diseases. Bondy et al., Care of girls and women with Turner Syndrome: A guideline of the Turner Syndrome Study Group. J Clin Endocrinol Metab 2006;92:10-25).

Expected Benefits:

Because modern treatments have led to greatly improved survival of patients with chronic diseases, the issue of long-term side-effects of the diseases has become an important one for advice to patients and (for children) to their parents. It is also important to clinicians deciding about treatment of diseases and the balance of benefit vs. side-effects and complications, and to the Health Service, because of the costs accruing for continued follow-up and care of these patients and the planning required to take account of long-term consequences and to plan strategies, where possible, for their prevention and early detection. There is a great desire on the part of parents of children born with cytogenetic abnormalities to know about their child’s prognosis, and the same is true for parents of children with endocrine diseases. The conditions, are ones where there is reason to be concerned about long-term mortality and cancer risks, and a deficiency of large-scale cohort information about this.

Overall the study would enable patients, their parents and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term morbidity and mortality, and therefore understand risks better and embark on a more personalised care pathway. In particular:-

1. The study will provide information on relative and absolute risks of the full spectrum of long-term site-specific cancer incidence and cause-specific mortality, which will make available a more informed knowledge base from which patients can ascertain their personal risks of developing a range of late effects through life than has previously been possible. This is important for patients to be able to make fully informed decisions on their care and for clinical decisions on long-term care, and will enable follow-up and screening schedules tailored to their personal risks and hence potentially to more patient-centred and effective follow-up, earlier diagnosis of adverse events, and improved outcomes.

2. By improving knowledge of risk complications, the results should contribute to consensus and guidelines for management of long-term hazards to improve outcomes, e.g. via screening tools and standardising of follow-up schedules.

3. The data provided would also provide important information for health service resource distribution and costings, to plan long-term management of these life-long conditions economically and effectively.

Outputs:

The planned outputs will include several published papers in high-profile peer-reviewed scientific journals, submitted over the next 2-3 years on the risks of cancer incidence and cause-specific mortality in patients with these conditions, with separate papers for different underlying conditions (see below, for examples).

The research was initially funded by the Medical Research Council, as part of a programme of health-related peer-reviewed research, funded by them, and produced several high-profile publications so NHS Digital can be assured that it will do so again with longer follow-up and hence more valuable results. The extended follow-up will also enable analyses of less-common conditions that ICR was unable to publish in the previous round of analyses because of limited numbers of cancers and deaths, and for which there are currently no published analyses available for parents and clinicians on risks of cancer and mortality. It will also enable far longer-term risks to be assessed (up to 60 years follow-up) than has previously been possible.

ICR will publicise the results to patients, their parents, and society more widely by press releases and blogs, to professional standard, from the Institute’s very active communications department; from information sent to patient-centred charities and help groups and put on our website, and by talks given to patient and lay groups as well as to appropriate medical speciality (paediatric endocrinology and genetics) conferences, meetings and seminars.

Processing:

The cohort identifiers were supplied many years ago and the participant’s entries were flagged on NHS Digital’s computer system. No new data will be shared with NHS Digital. NHS Digital has supplied data to the ICR at regular intervals. This data is used only for analyses for the approved medical research project identified above.

The data is not linked to other datasets other than the clinical source data and the NHS Digital data. Identifiable data are required to ensure accurate linkages of individual patients’ data. After the data sent by NHS Digital has been linked, the analysis is conducted on pseudo-anonymised files. The data will be accessed and analysed by the authorised Approved Researchers at ICR and solely at ICR, in order to produce the analyses described above, which are the purpose of the study and the purpose of obtaining the data from NHS Digital.

Data will only be accessed by individuals within the ICR who have authorisation from the Chief Investigator, who is the Head of the Epidemiology Section at the ICR. Access will only be authorised for the purposes described and for individuals who are substantive employees of the ICR.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

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).

MR400 - Cohort Study of People with Insulin Treated Diabetes — DARS-NIC-147748-XD18S

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , National Health Service Act 2006 - s251 - 'Control of patient information'. , Section 251 approval is in place for the flow of identifiable data, 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(7), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2018-08-01 — 2021-02-06 2017.09 — 2020.01.

Access method: Ongoing, One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Members and Postings Report
  5. MRIS - Flagging Current Status Report
  6. Cancer Registration Data
  7. Civil Registration - Deaths
  8. Demographics
  9. Civil Registrations of Death

Objectives:

The data supplied will be used only for the approved Medical Research Project - MR400 - Cohort Study of People with Insulin Treated Diabetes

Yielded Benefits:

Previous outputs from this study have been widely used for care of the relevant patients, as evidenced by the exceptionally high citation rates of the papers (in square brackets below): Swerdlow et al., Cancer incidence and mortality in patients with insulin-treated diabetes: a UK cohort study. Br J Cancer 2005;92:2070-5 [151 citations], Laing et al., Mortality from heart disease in a cohort of 23,000 patients with insulin-treated diabetes. Diabetologia 2003; 46:760-5 [645 citations], Laing et al., Mortality from cerebrovascular disease in a cohort of 23 000 patients with insulin-treated diabetes. Stroke 2003;34:418-21 [152 citations], dos Santos Silva et al., Birthweight and other pregnancy outcomes in a cohort of women with pre-gestational insulin-treated diabetes mellitus, Scotland, 1979-95. Diabet Med 2005;22:440-7 [38 citations], Laing et al., The British Diabetic Association Cohort Study, II: cause-specific mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:466-71 [387 citations], Laing et al., The British Diabetic Association Cohort Study, I: all-cause mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:459-65 [176 citations], Swerdlow et al., Mortality of South Asian patients with insulin-treated diabetes mellitus in the United Kingdom: a cohort study. Diabet Med 2004;21:845-51 [26 citations], Laing et al., Psychosocial and socioeconomic risk factors for premature death in young people with type 1 diabetes. Diabetes Care 2005;28:1618-23 [69 citations].

Expected Benefits:

Diabetes mellitus is the most common metabolic abnormality in Western populations. The health care costs and implications are very large. It occurs through two different primary disease processes, type I (insulin-dependent) and type II (non-insulin dependent), with different patient characteristics. Type I diabetes largely starts in childhood, and is one of the major childhood chronic diseases. With the introduction of insulin treatment in 1922, survival beyond a year or two became possible, but this entailed serious long-term consequences for risks of several major chronic diseases, especially cardiovascular diseases. Because modern treatments have led to greatly improved survival of patients with diabetes, the issue of long-term side-effects of the disease has become an important one for information and advice to patients and (for children) to their parents. It is also important to clinicians deciding about treatment of diabetes and the balance of benefit vs. side-effects and complications, and to the Health Service, because of the costs accruing for continued follow-up and care of these patients and the planning required to take account of long-term consequences and to plan strategies, where possible, for their prevention and early detection. The risks of cancer are also of major importance to patients and their families, and to clinical practice and health service planning, because cancer is one of the major causes of morbidity and death in the UK and type I diabetes requires lifelong treatment and follow-up. Data on very long term risks are limited, however.

The metabolic and hormonal antecedents and consequences of diabetes, and the treatments for it, might also affect the risk of cancer and this is important to know in order to guide screening regimens, enable early diagnosis, and follow-up. Most studies of cancer risks in patients with diabetes have related to type II diabetes, however, for which interpretation is uncertain because of potential confounding by obesity and alcohol consumption. Pancreatic cancer risk has been found raised, but there is uncertainty about the direction of causation, because pancreatic cancer can cause diabetes. The aetiology of type I diabetes is not related to obesity or alcohol use, and the diabetes generally occurs well before the ages at which pancreatic cancer is prevalent. Studies of cancer risk in patients with type I diabetes, however, have generally been relatively small.

ICR therefore inaugurated 25 years ago a long-term cohort study of mortality and cancer incidence in 29,500 patients in the UK with insulin-treated diabetes. It is much the largest cohort study of such patients in the world with such long follow-up, and is providing unique information, currently with up to 35 years follow-up, but in the future with longer follow-up, on the long-term consequences of diabetes and the extent to which duration of diabetes and age at onset are risk factors for mortality and morbidity. The ICR is not aware of other published cohort studies with information on these latter variables. The study is important to inform parents of children with diabetes, patients themselves, those treating the patients, and the health service, on the long-term consequences and prognosis of this chronic disease, which consumes considerable health service resources.

Overall the study will enable patients, their parents and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term morbidity and mortality, and therefore understand risks better and embark on a more personalised care pathway. In particular:-

1. The study will provide information on relative and absolute risks of the full spectrum of long-term site-specific cancer incidence and cause-specific mortality, and on life expectancy, which will provide a more informed knowledge base from which patients can ascertain their personal risks of developing a range of late effects through life than has previously been possible, and enable them to take into account the age at which they developed diabetes and the duration that has elapsed since. This is important for patients to be able to make fully informed decisions on their care and for clinical decisions on long-term care and will enable follow-up and screening schedules tailored to their personal risks and hence potentially to more patient-centred and effective follow-up, earlier diagnosis of adverse events, and improved outcomes.

2. By improving knowledge of risk complications, the results should contribute to consensus and guidelines for management of long-term hazards to improve outcomes, e.g. via screening tools and standardising of follow-up schedules.

3. The data provided would also provide important information for health service resource distribution and costings, to plan long-term management of this life-long condition, which gives rise to considerable health service provision costs, economically and effectively.

4. Improve understanding of disease aetiology and hence prevention by, for instance, illuminating the relation of cancer risks to duration of diabetes, and examining the relation of diabetes complications to age of onset of diabetes.

Outputs:

The planned outputs will include several published papers in high-profile peer-reviewed scientific journals, submitted over the next 2-3 years, and subsequently further papers with longer follow-up over the next 20 years on the risks of cancer incidence and cause-specific mortality in patients with type I diabetes, with analyses subdivided by age at onset of diabetes, duration since onset, and attained age (see below for examples).

The research was initially funded by the British Diabetic Association. It has produced several high-profile publications (references in section 5d. iii), so NHS Digital can be assured that it will do so again with longer follow-up and hence more valuable results. The extended follow-up will also enable analyses of less-common outcomes for which the ICR was unable to publish stable results in its previous round of analyses because of limited numbers of cancers and deaths, and for which there are currently no published analyses available for long durations, to inform patients, their parents and clinicians on risks. It will also enable far longer-term risks to be assessed (up to 45 years follow-up from study entry) than has previously been possible.

ICR will publicise the results to patients, their parents, and society more widely by press releases and blogs, to professional standard, from the Institute’s very active communications department, information sent to patient-centred charities (notably Diabetes UK) and help groups and put on the ICR’s website, and by talks given to patient and lay groups as well as to appropriate medical speciality (paediatric endocrinology and genetics) conferences, meetings and seminars.

Processing:

The cohort identifiers were supplied to ONS (then OPCS) many years ago and the participants’ entries were flagged on NHS Digital’s computer system. A cohort study, by definition, follows people with exposure information already collected (in this instance diagnostic information) to ascertain their subsequent risks of morbidity and/or mortality. ICR already holds the exposure (diagnostic) data and follow-up data up to the present (sent by NHS Digital and predecessor organisations over the last >20 years) and needs continuing follow-up data on cancer incidence, mortality and other losses to follow-up to enable analyses of cancer incidence and cause-specific mortality risks over longer periods for the benefit of current and future patients, and their health care. No new data will be shared with NHS digital. NHS Digital supplies quarterly data to the ICR. These data are used only for analyses for the approved medical research project identified above.

The data are not linked to other datasets other than the clinical source data and the ONS/NHS Digital data. Identifiable data are required to ensure accurate linkages of individual patients’ data. After the data sent by NHS Digital have been linked, the analysis is conducted on pseudo-anonymised files. The data will be accessed and analysed by the authorised Approved Researchers at ICR, in order to produce the analyses described above, which are the purpose of the study and the purpose of obtaining the data from NHS Digital.

Data will only be accessed by individuals within the ICR who have authorisation from the Principal Investigator of the study, to access the data for the purpose(s) described, all of whom are substantive employees of the Institute of Cancer Research.

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).

MR1211 - UK Genetic Prostate Cancer Study — DARS-NIC-148118-VCXW9

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, Anonymised - ICO Code Compliant, Yes, No (Reasonable Expectation, Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), , Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 - s261(5)(d); Health and Social Care Act 2012 – s261(2)(c); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2011-03-24 — 2020-05-31 2016.05 — 2020.01.

Access method: Ongoing, One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Scottish NHS / Registration
  5. MRIS - Members and Postings Report
  6. MRIS - Personal Demographics Service
  7. Cancer Registration Data
  8. Civil Registration - Deaths
  9. Demographics
  10. Civil Registrations of Death

Objectives:

The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. 31 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new drug treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival.
(see point 10)

Expected Benefits:

The UKGPCS has been running since 1992, and gained MREC approval in 2003. The study is UK wide and currently 162 hospitals recruit prostate cancer patients with young onset or familial prostate cancer into the study. The Royal Marsden Hospital has ethical approval to recruit prostate cancer patients of any age to the study. Currently there are 10,491 patients consented to the study, and the target is 21,000 by the end of 2012.
Each consented patient gives a blood sample, and a family history questionnaire, and we obtain clinical data from their consultant. Not all patients have given consent to re contact them and we do not have current addresses for many of the participants, some of whom were recruited more than 10 years ago.

Outputs:

The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer

Processing:

Standard time-to-event analysis will be used to test for association between genotype and prognosis. Time at risk will begin on the date of diagnosis, with time under observation beginning on date of blood sample receipt. Follow-up will be censored on the date of death from any cause, or, if death did not occur, on the date of the end of the study.
We already have genotype data, date of diagnosis and date of blood receipt for all our cases. We therefore request death certificate data to enable us to obtain date of death and cause of death for those men in UKGPCS who have died.
(see point 12)

MR287 - Study of Twins — DARS-NIC-147923-P5DTX

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, Identifiable (Section 251 NHS Act 2006)

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Section 251 approval is in place for the flow of identifiable data, 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(7), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2018-08-01 — 2021-02-05 2017.03 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. Cancer Registration Data
  7. Civil Registration - Deaths
  8. Demographics
  9. Civil Registrations of Death

Objectives:

The data supplied by the NHS IC to Institute of Cancer research will only be used for the approved Medical Research Project.

Yielded Benefits:

Previous outputs from this study have been widely used, as evidenced by the very high citation rates of the papers (in square brackets below): Swerdlow et al., Lancet 1997;350:1729-8 [204] Swerdlow et al., J Natl Cancer Inst. 2002;94:1238-46 [47] Swerdlow et al., Int J Cancer. 1996; 67:472-8 [27] Swerdlow et al., Br J Cancer. 1999;80:1098-102 [65]

Expected Benefits:

Finding the causes of cancer is important to enabling its prevention and identifying high risk groups for screening and early detection. Cancer now accounts for 31% of death in men and 26% of deaths in women in England, so is a major public health problem. Gaining information on familial and genetic risks of cancer is important, because these are questions that matter greatly to patients, and to health care and screening of their relatives, and also because they can give important insights more widely into the causes, and hence prevention, of cancer. Information on genetic risks is also important to health service planning and service provision of genetics and high risk clinics, and of high risk screening services. The study also gives direct information for patients who are twins and their co-twins. The likely risks of cancer in close members of their family is a major concern for cancer patients, on which they desire rigorous information.

Twin studies have unique potential to investigate both genetic and environmental/behavioural and prenatal aspects of disease aetiology, as well as to provide data to test hypothesised models of carcinogenesis. Such studies have made only a small contribution to investigation of cancer aetiology, however, reflecting the great difficulty of identifying large enough numbers of twins with cancer for site-specific analyses. This study has been running for over 20 years and has contributed unique data on several aspects of genetic and environmental/ prenatal aetiology of cancer. The ICR believes it is the only cancer study of its type in the UK, and for several cancers (e.g. testicular cancer, premenopausal breast cancer) it is much the largest of its type internationally. There is a great desire on the part of patients with cancer to know about their relatives’ risks. Cancer is a condition where there is good reason to be concerned about long-term serious risks for family members.

Overall the study would enable patients, their families and clinicians to undertake more-informed discussion and decision-making about the family’s risks of cancer, and hence to embark on a more personalised care pathway. In particular:

1. The study will contribute to information on relative and absolute risks of cancer incidence and site-specific mortality, for the benefit of patients and their relatives (especially twins, but also more generally), and from which clinicians can base advice, about familial and genetic risks of cancer. The likely risks of cancer in close members of their family is a major concern for cancer patients, on which they desire rigorous information. The likely risks of cancer in close members of their family is a major concern for cancer patients, on which they desire rigorous information. This will contribute to a more informed knowledge base from which patients and their families can ascertain the relative’s personal risks of developing cancer through life. This is important for patients and relatives to be able to make fully informed decisions on their care and for clinical decisions on long-term care, and will enable risk advice, follow-up and screening schedules tailored to their personal risks and hence potentially to more patient-centred and effective follow-up, earlier diagnosis of adverse events, and improved outcomes.

2. Information on genetic risks is also important to health service planning and service provision of genetics and high risk clinics, and of high risk screening services as well as for health service resource distribution and costings for these services.

3. The study will improve understanding of disease aetiology and hence prevention by illuminating the extent to which familial cancer risks are explicable by genes already known, which model of genetic aetiology would fit with twin data, and the extent of potentially modifiable, environmental/behavioural and prenatal causes of these cancers.

Outputs:

The planned outputs will include published papers in high-profile peer-reviewed scientific journals, submitted over the next 3 years, and subsequently further papers with longer follow-up over the next 20 years on the risks of site-specific cancer incidence and cause-specific mortality in twins. The research was initially funded by OPCS and the Cancer Research Campaign (now Cancer Research UK). It has produced several high-profile publications, so NHS Digital can be assured that it will do so again with longer follow-up and hence more valuable results to inform patients and clinicians on risks. It will also enable far longer-term risks to be assessed than has previously been possible.

ICR will publicise the results to patients and society more widely by press releases and blogs, to professional standard, from the Institute’s very active communications department, information sent to patient-centred charities and help groups and put on the ICR’s website, and by talks given to patient and lay groups as well as to appropriate medical specialty conferences, meetings and seminars.

Processing:

The study subjects were identified and flagged on the OPCS (now NHS Digital) and Scottish NHSCR computer systems more than 20 years ago and flagged for cancer incidence, mortality, and exits from risk. They had mainly been identified internally at OPCS by matching national cancer registry files on all cancer registrations for residents of England and Wales born since 29th September 1939 and registered incident in England and Wales during 1971-1984 with the National Health Service Central Register (NHSCR) and the national birth register. Cancer patients born in Scotland (i.e., with Scottish NHS numbers) were similarly traced at the Scottish NHSCR in Edinburgh, to determine their twin status and birth order. Also, for breast cancer, testicular cancer and ovarian cancer, this was extended to earlier years using birth microfiches from OPCS and sent the identified records to OPCS for flagging.

ICR already holds the data on the twin study subjects and follow-up data up to the present (sent by NHS Digital and predecessor organisations over the last >20 years) and needs continuing follow-up data on cancer incidence, mortality and other losses to follow-up to enable analyses of cancer incidence and cause-specific mortality risks over longer periods for the benefit of current and future patients, and their health care. No new data will be shared with NHS digital. NHS Digital routinely supplies data to the ICR. These data are used only for analyses for the approved medical research project identified above.

The data are not linked to datasets other than the ONS/NHS Digital data. Identifiable data are required to ensure accurate linkages of individual patients’ data. After the data sent by NHS Digital have been linked, the analysis is conducted on pseudo-anonymised files. The data will be accessed and analysed by authorised researchers at ICR, in order to produce the analyses described above, which are the purpose of the study and the purpose of obtaining the data from NHS Digital.

Data will only be accessed by individuals within the ICR who have authorisation from the Chief Investigator, who is the Head of the Epidemiology Team at the ICR. Access will only be authorised for the purposes described and for individuals who are substantive employees of the ICR.

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).

Project 9 — DARS-NIC-226323-X4L5B

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y ()

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2016.08.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report

Objectives:

As part of the ARTISTIC trial, between 2001-09, 24510 women underwent HPV testing with genotyping. This project concerns long-term follow-up of this unique cohort through notification of cancer and death. The aim is to evaluate the long-term value of HPV testing as a primary screening strategy. Cervical screening intervals of 6-10 years following a negative HPV test are now being considered and which demonstrates the importance of long-term data on cohorts such as ARTISTIC.
The universal introduction of primary HPV testing in the NHS cervical screening programme will require several practical decisions on test method and frequency with large effects on costs, staff time and patient acceptability, as well as on effectiveness of cancer prevention. Our findings will add to the body of evidence to allow policy -makers to improve the cervical screening programme in the UK (and around the world).
The results will be presented at international HPV conferences and published in peer-reviewed journals.
In addition, anonymised individual data (including events notified through this flagging process) has been pooled with 3 other European trials in order to evaluate the efficacy of HPV testing for preventing invasive cervical cancer (to be published in the Lancet shortly). In screened cohorts, invasive cervical cancer is so rare that pooling data with other large studies is the best way to evaluate this.