Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older
University of Warwick · Academic
Expired The latest version ended on 17 July 2026. The September 2026 register still lists the agreement, but its term has passed.
- Reference
- DARS-NIC-658720-R3V5Z
- Latest version
- v2.2
- Term of latest version
- 30 July 2024 to 17 July 2026
- Start date
- 18 July 2023
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 56
Why the data was released
Objective for processing
The University of Warwick, require access to NHS England data for the purpose of the following research project: Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older.
The Mammo-50 study is a multi-centre, phase III, randomised controlled trial (RCT) of annual mammography versus 2 yearly for conservation surgery patients and 3 yearly for mastectomy patients. There is also an observational cohort study offered to those patients for whom the specialist or patient opts for standard mammography per local practice or immediate discharge to the screening programme or stopping mammography altogether.
The following is a summary of the aims of the research project provided by the University of Warwick.
The aim of the Mammo-50 study is to investigate the most effective and safest way of monitoring women of 50 years or over at diagnosis, who have been treated surgically with curative intent for invasive and
non-invasive breast cancer, and are more than 3 years post-surgery. It will also consider acceptability to patients and cost-effectiveness. It may eventually inform national guidelines about the best way to follow up women who have had surgery for breast cancer. The observational cohort study will compare demographics and outcomes between these non-randomised participants and those that were randomised into the trial to inform the generalisability of the results of the RCT.
The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care, Critical Care and Outpatients: necessary to determine if there is a difference in survival, required hospital-based health care activity, and associated cost to the NHS between the trial arms, and in comparison, to the observational cohort.
• Civil Registrations Deaths and Cancer Registration data: necessary to determine if there is a difference in disease specific survival, recurrence of disease, and survival between the different treatment groups, and in comparison, to the observational cohort. Mortality data will be used to verify the data reported by participating NHS hospitals. For example, the University of Warwick will check whether there are any additional deaths identified in the Civil Registration Deaths data that have not already been reported via the Case Report Form, or where the date and/or cause of death is discrepant to that reported by the NHS hospital. Where there are additional or discrepant deaths identified, the University of Warwick trial team will ask the relevant NHS hospital to review the status of these participants and provide any new or corrected data to make the main trial dataset as complete as possible. No NHS England Data will be shared with the NHS hospitals during this process.
The level of data will be identifiable, which is necessary to enable linkage of the data with data collected from other sources and completion of the analysis, including data direct from the participants and the recruiting NHS hospital
The data will be minimised as follows:
Limited to a study cohort identified by the University of Warwick for the cohort of patients who are consented to participate in the Mammo-50 trial or the observational cohort study. The cohort of patients are all female, aged 50 or over at initial diagnosis, had excised invasive or non-invasive (DCIS) breast cancer with local treatment completed, had 3 years post curative surgery and showed no evidence of local recurrence or new breast cancer primary distant metastases or any new malignancies. Limited to data between 2014/15 to 2022/23. For each individual patient, HES data will only be provided from the date they consented to join the trial.
The University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) are Co-Sponsors for the MAMMO-50 study. The University of Warwick is the sole data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
Although UHCW is a co-sponsor, UHCW will not carry out any data controllership or processing activities.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place for the duration of the trial. The funder will have no ability to suppress or otherwise limit the publication of findings.
There are multiple clinical collaborators on the trial who have been involved with the management of the trial. This included advising on the data items the study should collect from the NHS sites who recruit and follow-up the cohort, at the beginning of the trial. They will not be involved, nor will they advise on the data processing, but they are likely to help interpret the aggregated results (with small numbers supressed) for the purposes of the report.
The trial has three oversight groups: the Trial Management Group (TMG), the independent Trial Steering Committee (TSC) and the independent Data Monitoring and Ethics Committee (DMEC).
The TMG includes a multidisciplinary team of clinicians, statisticians, translational scientist and a patient advocate who all have considerable expertise in all aspects of design, running, quality assurance and analysis of the trial. This group includes co-investigators as well as experts co-opted for their expertise. Only members of the TMG who are analysing the data for the purposes outlined above will have access to the data.
The TSC provides advice, through its chair, to the chief investigator, the trial sponsor, the trial funder, on all appropriate aspects of the trial. The DMEC provides advice to the TSC.
Data will be accessed by the team at the University of Warwick and by two individuals from the University of Leeds who hold honorary contracts with the University of Warwick.
A Public and Patient Information and Engagement group was consulted regarding the collection of the data for the purposes described above. The Independent Cancer Patients Voice (ICPV) was consulted, via an individual member of the group. The frequency of meetings varied from monthly to every 6 months.
Additionally, an individual patient representative for the Mammo-50 study, and user representatives of the National Cancer Research Institute (NCRI) breast cancer clinical study group, have been influential in defining the acceptability of the current trial design, alongside the ICPV. Patient representatives will be involved in the dissemination of study results.
Processing activities
The University of Warwick will transfer data to NHS England. The data will consist of identifying details, specifically, NHS Number, Date of Birth, and a unique person ID. Date of consent for each participant will be provided by the University of Warwick.
NHS England data will extract the relevant records from the HES datasets, Cancer Registrations, and Civil Registration Deaths and provide to the University of Warwick. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data from the MAMMO-50 study held by the University of Warwick.
The data will be stored as encrypted files on servers at University of Warwick. The data will be accessed by authorised personnel, both on-site and via remote access.
The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.
For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this 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 remain on the servers at the University of Warwick at all times. The data will not be transferred to any other location. There are no off-site backup services.
The data will not leave England at any time.
Data will be accessed by individuals employed by the University of Leeds with an honorary contract with the University of Warwick. The University of Leeds employees will act as agents at all times under supervision from employees of the University of Warwick. Aside from these individuals, access is restricted to employees or agents of the University of Warwick, who have authorisation from the Chief Investigator. All personnel accessing the data have been appropriately trained in data protection and confidentiality.
The identifying details (NHS and unique person ID) will be stored in a separate database to the linked dataset used for the analysis. Date of birth is required in the linked dataset to enable derivation of the outcome data.
Researchers from the University of Leeds and University of Warwick will analyse the data for the purposes described above. Anonymised outputs of the analysis will be made available to the University of Leeds in the form of aggregate outputs with small numbers supressed in line with HES Analysis Guide to run through economic modelling software. The output from the economic modelling will be returned to the University of Warwick for inclusion in the report and publications.
Expected output
The trial aims to show whether continued annual surveillance mammography is needed 3 years post curative surgery, by which time most women have been discharged from hospital follow-up. There is very little data to support continued annual surveillance mammography and this trial will fill the evidence gap. There is also a huge disparity in follow-up protocols adopted nationally and Mammo-50 aims to provide information as to the type of follow-up adopted at each hospital and acceptability to patients. The results of the trial are likely to be of interest globally to a clinical audience, policy makers, patients and the general public. Dissemination of trial results will be widespread and will inform clinical practice whatever the outcome.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The expected outputs of the processing will be:
- Journals: including the New England Journal for Medicine and the Lancet Oncology
- National and International Cancer Conferences
- NICE Guidelines - specifically NG101: Early and locally advanced breast cancer: diagnosis and management
- Social media platforms (Including Twitter).
- Patient Information leaflets will be prepared and made available at each study recruitment site, which shall feedback results to patients.
- Public promotion of the research: Cancer Research UK (CRUK) and BCN (Breast Cancer Now), and Independent Cancer Patients' Voice (ICPV) are aware of the study and lay summaries will be made available on, for example, relevant websites.
In line with funding requirements, a report will be submitted to the NIHR summarising the trial results, including the cost-effectiveness analyses. The deadline for submitting the final report is 31st December 2023; the report will be published in the NIHR Journals Library.
The aim will be to present the findings of the report at the San Antonio Breast Cancer Symposium (SABCS). The study will also aim to share their findings with the New England Journal for Medicine, Health Economics Paper and the Lancet Oncology. It is hoped outputs will be available late 2023 / 2024.
The intention is for outputs to be published with open access.
Expected measurable benefits
The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.
Current methods of follow-up involving clinical examination by a specialist as well as mammography are costly, time-consuming and stressful for patients if carried out long after diagnosis. Given that breast cancer is becoming more common with around 55,900 new cases diagnosed annually in the UK and survival is improving, the cost of follow-up represents a significant and increasing burden for the NHS. There is no clear evidence for the optimum frequency or duration of mammograms. Current NICE guidance advises annual mammograms for a minimum of five years post diagnosis. However, a report published in 2011 by the NIHR HTA confirmed earlier studies that showed widespread disparity in the frequency and duration of mammographic and clinical review for both invasive and non-invasive breast cancer. They also found that some patients may require mammograms only three-yearly, provided they are monitored and supported in alternative ways. It is hoped the Mammo-50 trial will meet an urgent need to establish the optimum cost-effective mammographic surveillance regimen. The trial is expected to confirm whether patients will not be disadvantaged by having less frequent surveillance mammograms, which would mean reduced visits to the hospital and subsequently reduced stress.
Mammo-50 is the first large scale randomised controlled trial to rigorously test the acceptability and effectiveness of follow-up with risk adjusted mammographic surveillance and clinical examination but underpinned by the new technology of digital imaging, data linkage and consumer-led incident reporting to track events both in the short and long term. The rigorous design and evaluation will provide evidence on high and low risk groups with regard to cancer recurrence and treatment morbidity. Benefits are likely to include cost saving to the NHS, patients and families.
The study anticipates identifying cost savings in excess of £1.2 million annually from over provision of mammograms or specialist clinical examination and associated treatments to low risk, low benefit patients which may in part contribute to the provision of extra assessments, examinations or treatments to those few patients at greatest risk of further disease. The data obtained from NHS England may enable the study to assess the primary endpoint of the trial, but also estimate the annual savings to the NHS by capturing differences in hospital resource use.
The dissemination may potentially be widespread and may change clinical practice whatever the outcomes. The questions addressed in this proposal are important to patients, professionals and policy makers in order to optimise services. As part of a collaboration between NCRI, NIHR CRN, NICE and NHS England on an initiative to improve the speed of adoption of clinical trial results into routine NHS practice, Mammo-50 is flagged with NICE as potentially practice-changing. NICE is tracking the progress of Mammo-50, awaiting the reporting of the primary endpoint, with the aim of triggering planning for implementing changes to the NICE Guidelines sooner.
Benefits reported so far
No yielded benefits to date, as the University of Warwick have yet to receive the entirety of the data originally requested.
Datasets on the latest version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Cancer Registration Data | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
| Civil Registrations of Death | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Critical Care (HES Critical Care) | Identifiable | Non-Sensitive | One-Off | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Outpatients (HES OP) | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were not applied to any of the 56 files released under this agreement, across every version. About opt-outs
No files recorded as released under the latest version. 56 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-658720-R3V5Z-v2.2 30 July 2024 to 17 July 2026
- Title
- Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 0
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-658720-R3V5Z-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-07-30 |
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.
DARS-NIC-658720-R3V5Z-v1.2 6 December 2023 to 17 July 2026
- Title
- Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 30
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-658720-R3V5Z-v0.10
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-12-06 |
Objective for processing
[5 paragraphs unchanged]
DATA REQUESTED:
[4 paragraphs unchanged]
DATA MINIMISATION:
[2 paragraphs unchanged]
DATA CONTROLLERSHIP:
[2 paragraphs unchanged]
GDPR LEGAL BASIS:
[5 paragraphs unchanged]
FUNDING:
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place for the duration of the trial. The funder will have no ability to suppress or otherwise limit the publication of findings.
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place until December 2023. The funder will have no ability to suppress or otherwise limit the publication of findings.
ORGANISATIONS INVOLVED IN AN ADVISORY CAPACITY
[4 paragraphs unchanged]
DATA ACCESS:
[1 paragraph unchanged]
PATIENT AND PUBLIC INVOLVEMENT:
[2 paragraphs unchanged]
Processing activities
[2 paragraphs unchanged]
The data will be stored as encrypted files on servers at University of Warwick. The data will be accessed by authorised personnel, both on-site and via remote access.
The data will remain on the servers at the University of Warwick at all times. The data will not be transferred to any other location. There are no off-site backup services.
The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.
For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this 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 remain on the servers at the University of Warwick at all times. The data will not be transferred to any other location. There are no off-site backup services.
[4 paragraphs unchanged]
Benefits reported
Yielded Benefits is not a requirement for new applications.
No yielded benefits to date, as the University of Warwick have yet to receive the entirety of the data originally requested.
Unchanged: Expected output, Expected measurable benefits.
Objective for processing
The University of Warwick, require access to NHS England data for the purpose of the following research project: Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older.
The Mammo-50 study is a multi-centre, phase III, randomised controlled trial (RCT) of annual mammography versus 2 yearly for conservation surgery patients and 3 yearly for mastectomy patients. There is also an observational cohort study offered to those patients for whom the specialist or patient opts for standard mammography per local practice or immediate discharge to the screening programme or stopping mammography altogether.
The following is a summary of the aims of the research project provided by the University of Warwick.
The aim of the Mammo-50 study is to investigate the most effective and safest way of monitoring women of 50 years or over at diagnosis, who have been treated surgically with curative intent for invasive and
non-invasive breast cancer, and are more than 3 years post-surgery. It will also consider acceptability to patients and cost-effectiveness. It may eventually inform national guidelines about the best way to follow up women who have had surgery for breast cancer. The observational cohort study will compare demographics and outcomes between these non-randomised participants and those that were randomised into the trial to inform the generalisability of the results of the RCT.
The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care, Critical Care and Outpatients: necessary to determine if there is a difference in survival, required hospital-based health care activity, and associated cost to the NHS between the trial arms, and in comparison, to the observational cohort.
• Civil Registrations Deaths and Cancer Registration data: necessary to determine if there is a difference in disease specific survival, recurrence of disease, and survival between the different treatment groups, and in comparison, to the observational cohort. Mortality data will be used to verify the data reported by participating NHS hospitals. For example, the University of Warwick will check whether there are any additional deaths identified in the Civil Registration Deaths data that have not already been reported via the Case Report Form, or where the date and/or cause of death is discrepant to that reported by the NHS hospital. Where there are additional or discrepant deaths identified, the University of Warwick trial team will ask the relevant NHS hospital to review the status of these participants and provide any new or corrected data to make the main trial dataset as complete as possible. No NHS England Data will be shared with the NHS hospitals during this process.
The level of data will be identifiable, which is necessary to enable linkage of the data with data collected from other sources and completion of the analysis, including data direct from the participants and the recruiting NHS hospital
The data will be minimised as follows:
Limited to a study cohort identified by the University of Warwick for the cohort of patients who are consented to participate in the Mammo-50 trial or the observational cohort study. The cohort of patients are all female, aged 50 or over at initial diagnosis, had excised invasive or non-invasive (DCIS) breast cancer with local treatment completed, had 3 years post curative surgery and showed no evidence of local recurrence or new breast cancer primary distant metastases or any new malignancies. Limited to data between 2014/15 to 2022/23. For each individual patient, HES data will only be provided from the date they consented to join the trial.
The University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) are Co-Sponsors for the MAMMO-50 study. The University of Warwick is the sole data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
Although UHCW is a co-sponsor, UHCW will not carry out any data controllership or processing activities.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place for the duration of the trial. The funder will have no ability to suppress or otherwise limit the publication of findings.
There are multiple clinical collaborators on the trial who have been involved with the management of the trial. This included advising on the data items the study should collect from the NHS sites who recruit and follow-up the cohort, at the beginning of the trial. They will not be involved, nor will they advise on the data processing, but they are likely to help interpret the aggregated results (with small numbers supressed) for the purposes of the report.
The trial has three oversight groups: the Trial Management Group (TMG), the independent Trial Steering Committee (TSC) and the independent Data Monitoring and Ethics Committee (DMEC).
The TMG includes a multidisciplinary team of clinicians, statisticians, translational scientist and a patient advocate who all have considerable expertise in all aspects of design, running, quality assurance and analysis of the trial. This group includes co-investigators as well as experts co-opted for their expertise. Only members of the TMG who are analysing the data for the purposes outlined above will have access to the data.
The TSC provides advice, through its chair, to the chief investigator, the trial sponsor, the trial funder, on all appropriate aspects of the trial. The DMEC provides advice to the TSC.
Data will be accessed by the team at the University of Warwick and by two individuals from the University of Leeds who hold honorary contracts with the University of Warwick.
A Public and Patient Information and Engagement group was consulted regarding the collection of the data for the purposes described above. The Independent Cancer Patients Voice (ICPV) was consulted, via an individual member of the group. The frequency of meetings varied from monthly to every 6 months.
Additionally, an individual patient representative for the Mammo-50 study, and user representatives of the National Cancer Research Institute (NCRI) breast cancer clinical study group, have been influential in defining the acceptability of the current trial design, alongside the ICPV. Patient representatives will be involved in the dissemination of study results.
Expected output
The trial aims to show whether continued annual surveillance mammography is needed 3 years post curative surgery, by which time most women have been discharged from hospital follow-up. There is very little data to support continued annual surveillance mammography and this trial will fill the evidence gap. There is also a huge disparity in follow-up protocols adopted nationally and Mammo-50 aims to provide information as to the type of follow-up adopted at each hospital and acceptability to patients. The results of the trial are likely to be of interest globally to a clinical audience, policy makers, patients and the general public. Dissemination of trial results will be widespread and will inform clinical practice whatever the outcome.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The expected outputs of the processing will be:
- Journals: including the New England Journal for Medicine and the Lancet Oncology
- National and International Cancer Conferences
- NICE Guidelines - specifically NG101: Early and locally advanced breast cancer: diagnosis and management
- Social media platforms (Including Twitter).
- Patient Information leaflets will be prepared and made available at each study recruitment site, which shall feedback results to patients.
- Public promotion of the research: Cancer Research UK (CRUK) and BCN (Breast Cancer Now), and Independent Cancer Patients' Voice (ICPV) are aware of the study and lay summaries will be made available on, for example, relevant websites.
In line with funding requirements, a report will be submitted to the NIHR summarising the trial results, including the cost-effectiveness analyses. The deadline for submitting the final report is 31st December 2023; the report will be published in the NIHR Journals Library.
The aim will be to present the findings of the report at the San Antonio Breast Cancer Symposium (SABCS). The study will also aim to share their findings with the New England Journal for Medicine, Health Economics Paper and the Lancet Oncology. It is hoped outputs will be available late 2023 / 2024.
The intention is for outputs to be published with open access.
Benefits reported
No yielded benefits to date, as the University of Warwick have yet to receive the entirety of the data originally requested.
DARS-NIC-658720-R3V5Z-v0.10 18 July 2023 to 17 July 2026
- Title
- Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 26
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP)
Objective for processing
The University of Warwick, require access to NHS England data for the purpose of the following research project: Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older.
The Mammo-50 study is a multi-centre, phase III, randomised controlled trial (RCT) of annual mammography versus 2 yearly for conservation surgery patients and 3 yearly for mastectomy patients. There is also an observational cohort study offered to those patients for whom the specialist or patient opts for standard mammography per local practice or immediate discharge to the screening programme or stopping mammography altogether.
The following is a summary of the aims of the research project provided by the University of Warwick.
The aim of the Mammo-50 study is to investigate the most effective and safest way of monitoring women of 50 years or over at diagnosis, who have been treated surgically with curative intent for invasive and
non-invasive breast cancer, and are more than 3 years post-surgery. It will also consider acceptability to patients and cost-effectiveness. It may eventually inform national guidelines about the best way to follow up women who have had surgery for breast cancer. The observational cohort study will compare demographics and outcomes between these non-randomised participants and those that were randomised into the trial to inform the generalisability of the results of the RCT.
DATA REQUESTED:
The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care, Critical Care and Outpatients: necessary to determine if there is a difference in survival, required hospital-based health care activity, and associated cost to the NHS between the trial arms, and in comparison, to the observational cohort.
• Civil Registrations Deaths and Cancer Registration data: necessary to determine if there is a difference in disease specific survival, recurrence of disease, and survival between the different treatment groups, and in comparison, to the observational cohort. Mortality data will be used to verify the data reported by participating NHS hospitals. For example, the University of Warwick will check whether there are any additional deaths identified in the Civil Registration Deaths data that have not already been reported via the Case Report Form, or where the date and/or cause of death is discrepant to that reported by the NHS hospital. Where there are additional or discrepant deaths identified, the University of Warwick trial team will ask the relevant NHS hospital to review the status of these participants and provide any new or corrected data to make the main trial dataset as complete as possible. No NHS England Data will be shared with the NHS hospitals during this process.
The level of data will be identifiable, which is necessary to enable linkage of the data with data collected from other sources and completion of the analysis, including data direct from the participants and the recruiting NHS hospital
DATA MINIMISATION:
The data will be minimised as follows:
Limited to a study cohort identified by the University of Warwick for the cohort of patients who are consented to participate in the Mammo-50 trial or the observational cohort study. The cohort of patients are all female, aged 50 or over at initial diagnosis, had excised invasive or non-invasive (DCIS) breast cancer with local treatment completed, had 3 years post curative surgery and showed no evidence of local recurrence or new breast cancer primary distant metastases or any new malignancies. Limited to data between 2014/15 to 2022/23. For each individual patient, HES data will only be provided from the date they consented to join the trial.
DATA CONTROLLERSHIP:
The University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) are Co-Sponsors for the MAMMO-50 study. The University of Warwick is the sole data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
Although UHCW is a co-sponsor, UHCW will not carry out any data controllership or processing activities.
GDPR LEGAL BASIS:
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
FUNDING:
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place until December 2023. The funder will have no ability to suppress or otherwise limit the publication of findings.
ORGANISATIONS INVOLVED IN AN ADVISORY CAPACITY
There are multiple clinical collaborators on the trial who have been involved with the management of the trial. This included advising on the data items the study should collect from the NHS sites who recruit and follow-up the cohort, at the beginning of the trial. They will not be involved, nor will they advise on the data processing, but they are likely to help interpret the aggregated results (with small numbers supressed) for the purposes of the report.
The trial has three oversight groups: the Trial Management Group (TMG), the independent Trial Steering Committee (TSC) and the independent Data Monitoring and Ethics Committee (DMEC).
The TMG includes a multidisciplinary team of clinicians, statisticians, translational scientist and a patient advocate who all have considerable expertise in all aspects of design, running, quality assurance and analysis of the trial. This group includes co-investigators as well as experts co-opted for their expertise. Only members of the TMG who are analysing the data for the purposes outlined above will have access to the data.
The TSC provides advice, through its chair, to the chief investigator, the trial sponsor, the trial funder, on all appropriate aspects of the trial. The DMEC provides advice to the TSC.
DATA ACCESS:
Data will be accessed by the team at the University of Warwick and by two individuals from the University of Leeds who hold honorary contracts with the University of Warwick.
PATIENT AND PUBLIC INVOLVEMENT:
A Public and Patient Information and Engagement group was consulted regarding the collection of the data for the purposes described above. The Independent Cancer Patients Voice (ICPV) was consulted, via an individual member of the group. The frequency of meetings varied from monthly to every 6 months.
Additionally, an individual patient representative for the Mammo-50 study, and user representatives of the National Cancer Research Institute (NCRI) breast cancer clinical study group, have been influential in defining the acceptability of the current trial design, alongside the ICPV. Patient representatives will be involved in the dissemination of study results.
Expected output
The trial aims to show whether continued annual surveillance mammography is needed 3 years post curative surgery, by which time most women have been discharged from hospital follow-up. There is very little data to support continued annual surveillance mammography and this trial will fill the evidence gap. There is also a huge disparity in follow-up protocols adopted nationally and Mammo-50 aims to provide information as to the type of follow-up adopted at each hospital and acceptability to patients. The results of the trial are likely to be of interest globally to a clinical audience, policy makers, patients and the general public. Dissemination of trial results will be widespread and will inform clinical practice whatever the outcome.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The expected outputs of the processing will be:
- Journals: including the New England Journal for Medicine and the Lancet Oncology
- National and International Cancer Conferences
- NICE Guidelines - specifically NG101: Early and locally advanced breast cancer: diagnosis and management
- Social media platforms (Including Twitter).
- Patient Information leaflets will be prepared and made available at each study recruitment site, which shall feedback results to patients.
- Public promotion of the research: Cancer Research UK (CRUK) and BCN (Breast Cancer Now), and Independent Cancer Patients' Voice (ICPV) are aware of the study and lay summaries will be made available on, for example, relevant websites.
In line with funding requirements, a report will be submitted to the NIHR summarising the trial results, including the cost-effectiveness analyses. The deadline for submitting the final report is 31st December 2023; the report will be published in the NIHR Journals Library.
The aim will be to present the findings of the report at the San Antonio Breast Cancer Symposium (SABCS). The study will also aim to share their findings with the New England Journal for Medicine, Health Economics Paper and the Lancet Oncology. It is hoped outputs will be available late 2023 / 2024.
The intention is for outputs to be published with open access.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
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September 2023 —
first listed. 1 version: DARS-NIC-658720-R3V5Z-v0.10
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February 2024
1 version added: DARS-NIC-658720-R3V5Z-v1.2
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November 2024
1 version added: DARS-NIC-658720-R3V5Z-v2.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-658720-R3V5Z, “Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-658720-r3v5z/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-658720-R3V5Z to see the original rows.