NHS Digital Data Release Register - reformatted

The Institute Of Cancer Research projects

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

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Identifiable (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2024-11-04 — 2027-10-05

Access method: One-Off

Data-controller type: INSTITUTE OF CANCER RESEARCH

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Pathway
  2. NDRS Cancer Registrations
  3. NDRS Linked HES APC
  4. NDRS Linked HES Outpatient
  5. NDRS National Radiotherapy Dataset (RTDS)
  6. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

The Institute of Cancer Research (ICR) requires access to NHS England data for the purpose of the following research project: Late effects of modern breast cancer treatments in England.

Due to great advancements in screening and treatment for breast cancer more than 80% of women diagnosed with breast cancer now survive 10 years or more (Breast cancer statistics, 2015). There are now more than 600,000 breast cancer survivors in the UK and ensuring their long-term health and quality of life is an important clinical and public health goal. An important question in this area is the long-term health effects of breast cancer treatments. Whilst clinical trials provide critical evidence on treatment efficacy there often lack long-term follow-up or sufficient sample size to capture late, but potentially serious side-effects such as radiation-related subsequent cancers. Real world evidence from large national linkages plays a critical role in evaluating these late-effects in a representative patient population. Linkage of the unique NHS treatment datasets, the NDRS Radiotherapy Data Set (RTDS) and NDRS Systemic Anti-Cancer Therapy (SACT) with the NDRS cancer registrations and NDRS linked hospital episode statistics provides a powerful tool for studying these questions.

This retrospective study aims to investigate the late effects of treatment in breast cancer survivors in a national cohort to provide real-world evidence (RWE) for modern breast cancer treatment regimens.
Specifically, the study team will assess the risks of subsequent malignancies, cardiovascular and other chronic diseases in relation to specific types of radiotherapy and chemotherapy received by breast cancer patients.

The following is a summary of the aims of the research project:
1. Investigate the association between moderate- and ultra-hypofractionated radiotherapy for breast cancer and the risk of second malignancies.
2. Examine the relationship between moderate- and ultra-hypofractionated radiotherapy for breast cancer and the risk of radiation-induced cardiovascular disease.
3. Compare the risk of breast cancer mortality and breast cancer recurrence from hypofractionated compared to conventional fractionated radiotherapy in breast cancer survivors.
4. Evaluate the risk of second malignancies and cardiovascular disease from other breast cancer treatments including chemotherapy and hormonal therapy.

The following NHS England Data will be accessed:

NDRS Cancer Registration Data: necessary to form the cohort of all breast cancer patients in England so the following can be created, a national breast cancer cohort and study patient outcomes including second cancers, breast cancer mortality and breast cancer recurrence.

NDRS Cancer Pathway Data: necessary as the Cancer Pathway holds data on patient treatment and outcomes, such as breast cancer recurrence.

NDRS National Radiotherapy Dataset (RTDS): necessary to study the risk of second cancers and cardiovascular disease after radiotherapy. The RTDS will be utilised to assess whether breast cancer patients received standard or hypofractionated radiotherapy using dose and fraction variables available in the RTDS.

NDRS Systemic Anti-Cancer Therapy Data (SACT): necessary to analyse the risk of second cancers and cardiovascular disease after chemotherapy and hormonal therapy.

NDRS linked Hospital Episode Statistics Admitted Care Data: necessary to ascertain outcomes in the breast cancer survivors including cardiovascular disease and breast cancer recurrence.

NDRS linked HES Outpatient Data (HES-OP): necessary to ascertain outcomes in the breast cancer survivors including cardiovascular disease and breast cancer recurrence.

Access to the NDRS Cancer Pathway, NDRS Cancer Registrations, NDRS Radiotherapy Dataset and the NDRS Systemic Anti-Cancer Therapy Dataset is necessary to evaluate outcomes after breast cancer (including mortality, breast cancer recurrence and other diseases) in relation to radiotherapy regimens received (standard, moderate and ultra hypofractionation) and other treatment modalities received by breast cancer patients.

Access to NDRS Linked HES Admitted Patient Care and NDRS Linked HES Outpatients is necessary for the study team to apply algorithms developed to ascertain breast cancer recurrence and non-cancer outcomes in the breast cancer patients.

The level of the data required will be :
• Pseudonymised

The data requested will be minimised and the cohort defined as follows:
• Women aged 18 to 85 years, of all ethnicities and residents in England.
• Women diagnosed with primary invasive breast cancer (ICD 10-02: C50x) or ductal carcinoma in situ (ICD 10-02: D05x) who have had no tumour of any type previously, other than non-melanoma. Patients with a previous D-code before breast cancer should be included in the cohort. In instances, where patients have a previous D-code before first invasive breast cancer, data on the D-code diagnosis will be included to conduct sensitivity analyses.
• Patients diagnosed from 1995 onwards.

The ICR is the sole controller responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller:

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

The processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public. This processing aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by Institute of Cancer Research Department of Clinical Epidemiology. The funding is specifically for the study described. Funding is in place until 2028.

A consultant medical oncologist at The Royal Marsden Hospital will provide clinical advice on the study. The input of Royal Marsden Hospital will be providing oversight only and will be working in an advisory capacity and will not have access to the data.

Access and analyses will be restricted to employees of The ICR within the Genetics and Epidemiology Clinical Cancer Epidemiology Division and a PhD student enrolled with The ICR. who are given authorisation by the principal investigator of the study.

The individuals have completed mandatory data protection and confidentiality training and are subject to ICR’s policies on data protection and confidentiality. The individuals accessing the data will do so under the supervision of a substantive employee of the ICR.

A patient engagement group will be convened in collaboration with The Royal Marsden Hospital when this Data Sharing Agreement is in place to provide support for the research and aid in developing patient information sheets to communicate the findings. The head of Patient and Public Involvement & Engagement (PPIE) at The Royal Marsden will provide support for PPIE to the ICR and advise on the development of the PPIE activities. There will be annual meetings to get patient input on the specific research questions, interpretation of findings and development of patient information sheets to communicate the findings.

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

Expected Benefits:

The findings from the research are expected to contribute to evidence-based decision-making for breast cancer treatments and to inform follow-up care for breast cancer survivors by raising awareness of the risks of late-effects of specific treatments. This could include design of screening or surveillance programmes for those identified as at especially high risk. It is hoped that this will improve patient outcomes if side-effects are identified early or treatment decisions are made to reduce the risks of side-effects. More generally the results may inform understanding of the side-effects from high-dose radiation exposures and specific chemotherapy agents, which could also apply to other patient populations.

The use of the data could:

• Help the system to better understand the health and care needs of populations.
• Lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• Inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• Provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
• Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions or developing clinical health guidelines for or within the NHS or treatment decisions in relation to specific patients.

The findings will be disseminated as described above, which will ensure promoting the results within the scientific community and the public which will increase the impact. ICR may translate the scientific findings to the public. The researchers in this project will stay informed about current work of relevant advisory bodies and will share the findings in call for evidence when and where it is considered suitable.

Outputs:

The expected outputs of the processing will be:

-Publication of papers in peer-reviewed scientific journals that will evaluate the late-effects of breast cancer treatments including subsequent malignancies, cardiovascular disease and other chronic conditions.
-Presentations at The European Society for Radiology and Oncology (ESTRO) and ICR conference
-Patient information sheets
-Study findings will also be presented at relevant scientific conferences

There will be work done with the patient engagement group to develop patient information sheets and interpret results to communicate the findings.

All outputs will be at the aggregate level with small numbers suppressed.

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

- Journals
-Findings will be shared through the ICR's Social media team
-Posters displayed at scientific conferences
-Patient Information leaflets available at the ICR or The Royal Marsden Hospital. Depending on the
findings from this research The Royal Marsden may aid in developing patient information sheets to
communicate the findings of the study
-Communication with clinicians, for example through the weekly academic breast cancer meeting with the Royal Marsden Hospital

Findings from this study will be published in peer-reviewed journals from 1.5 to 4 years after the receipt of the data. The expected frequency is 1-2 publications per year. Findings from this study's analyses relating to the first aim will be presented at conferences mentioned above within 2 years of receiving the data.

Processing:

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

NHS England will provide the relevant records from the datasets listed below to The ICR.

NDRS Cancer Registry
NDRS Cancer Pathway
NDRS Systematic Anti-Cancer Therapy Dataset (SACT)
NDRS Linked Radiotherapy Dataset (RTDS)
NDRS Linked HES Admitted Care (IP)
NDRS Linked Outpatients Hospital Episodes Statistics (HES OP)

The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The data will be stored and processed solely on services at ICR via a Secure Data Environment using a Data Safehaven with restricted access. The data will be accessed onsite at the premises of ICR and by authorised personnel via remote access on ICR devices.

The ICR complies with the controls for remote access as confirmed by the ICR Chief Information Security Officer.

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

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England/ Wales at any time.

Access is restricted to individuals within the Genetics and Epidemiology Clinical Cancer Epidemiology Division of The ICR who have authorisation from the Principal Investigator. Individuals are substantive employees of ICR and an enrolled PhD student with The ICR.

Authorised individuals will be permitted to access and analyse the pseudonymised data and will have been appropriately trained in data protection and confidentiality before gaining access to the datafiles.

The Data will not be linked with any other data that is outside of this data sharing agreement.

There will be no requirement and no attempt to reidentify individuals when using the Data. No identifiable information will be requested from NHS England, the data provided to ICR will be pseudonymised at the person record level. Analysis will use a pseudonymised dataset with unique patient IDs

Researchers from the ICR within the Genetics and Epidemiology Clinical Cancer Epidemiology Division will process/analyse the Data for the purposes described above.