Multifrequency Bioimpedance in the Early Detection of Lymphoedema
Manchester University NHS Foundation Trust · NHS Trust
In term In term in the September 2026 edition: the latest version runs to 12 June 2031.
- Reference
- DARS-NIC-656836-T2J0T
- Current version
- v3.5
- Term of current version
- 13 June 2025 to 12 June 2031
- Start date
- Before 26 June 2023
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 0
Why the data was released
Objective for processing
Manchester University NHS Foundation Trust requires access to NHS England data for the purpose of the following clinical trial:
Multifrequency Bioimpedance in the Early Detection of Lymphoedema.
The primary aim of the trail is to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial and to improve survival and reduce unwarranted variations in care for future breast cancer patients.
The BEA trial was an National Institute for Health and Care Research (NIHR) funded study and the data from the study needs to be retained for 10 years from the study end date.
The trial is now complete. Medicines and Healthcare products Regulatory Agency (MHRA) guidance stipulates that clinical trials should retain data for 15 years post trial.
Manchester University NHS Foundation Trust would like to retain this Data to ensure reconstruction of the trial analysis is possible if required.
No additional data will be requested from NHS England.
This Data Sharing Agreement (DSA) permits processing of the Data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Manchester University NHS Foundation Trust contact via the publishing journal or an open letter. In such circumstances, Manchester University NHS Foundation Trust may repeat the previously analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.
Manchester University NHS Foundation Trust may not undertake different analyses to those undertaken during the original analysis.
This DSA does not permit any onward sharing of the Data with the exception that the Data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA maintains a list of all clinical trials registered with them and reserve the right to audit the trial at any point from when the trial is opened to 5-year post trial closure.
A sponsoring organisation and/or the controller itself may also exercise the right to audit.
This DSA permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, Manchester University NHS Foundation Trust must confirm destruction to NHS England.
If any further data processing is required in addition to the above purposes or if the Data needs to be moved to a different location/organisation Manchester University NHS Foundation Trust must submit an Amendment request to NHS England before Data is accessed.
Data from the following NHS England Data will be retained:
- NDRS Cancer Registrations,
- NDRS linked Cancer Waiting Times (CWT),
- NDRS linked HES Accident and Emergency (HES AE),
- NDRS linked HES Admitted Patient Care (HES APC),
- NDRS linked HES outpatient (HES OP),
- NDRS National Radiotherapy Dataset (RTDS).
The level of Data being retained will be:
· Pseudonymised
The Data was minimised as follows:
- Limited to the fields defined in the “DARS-NIC-656836-T2J0T-v0.2 - DATA DICTIONARY 14052020" which can be found in the supporting documents
Manchester University NHS Trust is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
University of Manchester was previously listed as a data processor in the previous iteration of this agreement but has no more involvement under the current agreement.
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 funding is provided by National Institute for Health Research. The funding is specifically for the study described.
Processing activities
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).
Manchester University NHS Foundation Trust holds the relevant records from the:
- NDRS Cancer Registrations,
- NDRS linked Cancer Waiting Times (CWT),
- NDRS linked HES Accident and Emergency (HES AE),
- NDRS linked HES Admitted Patient Care (HES APC),
- NDRS linked HES outpatient (HES OP),
- NDRS National Radiotherapy Dataset (RTDS).
The Data will contain no direct identifying data items. The Data is pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.
No additional data will be disseminated by NHS England for the purposes of this DSA.
This DSA permits processing of the Data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
This DSA does not permit any onward sharing of the Data with the exception that the Data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA)
The Data will be stored on servers at Manchester University NHS Foundation Trust
In the event that the Data needs to be accessed for the purposes of audit or to enable verification of previous findings, the dataset would be transferred back to the Manchester University NHS Foundation Trust servers with authorisation from the Principal Investigator where it can be accessed by the study statistician only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.
The data may not be transferred to any other location and may only be accessed by substantive employees of Manchester University NHS Foundation Trust for the purposes described above.
This DSA is required for the following reasons;
The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit;
An audit may be required during the period of this DSA. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.
Expected output
The expected outputs of the processing will be:
- To determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial.
- A journal article will be produced as a result of this processing.
The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
- Newsletter to patients (Participant newsletters)
- Publication on MFT website.
-Publications and dissemination of results through the NIHR and Association of Breast Surgeons.
The study analysis will be complete by June 2025. It is expected the results for the study will be published later in 2025.
Expected measurable benefits
The data provided by NHS England allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. With this analysis, the aim is to improve survival and reduce unwarranted variations in care.
It is intended that the data will be used in a future study to analyse the effect of radiotherapy on arm and shoulder movement symptoms and development of lymphoedema. This will be done subject to regulatory approvals obtained and agreed by NHS England. The Chief investigator will pursue a separate data sharing agreement for this purpose.
The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.
The aim of this analysis is to improve survival and reduce unwarranted variations in care for future breast cancer patients.
It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.
Benefits reported so far
The data provided by NHS England allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. The study team have submitted the draft journal article of these results for publication; however, is not yet published. Publication is expected by end of 2025.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(a)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| NDRS Cancer Registrations | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
| NDRS Linked Cancer Waiting Times (Treatments only) | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
| NDRS Linked HES AE | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
| NDRS Linked HES APC | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
| NDRS Linked HES Outpatient | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
| NDRS National Radiotherapy Dataset (RTDS) | Anonymised - ICO Code Compliant | Sensitive | One-Off | Does not include the flow of confidential data |
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.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions — earlier versions exist, but none has been listed in an edition this site holds.
DARS-NIC-656836-T2J0T-v3.5 13 June 2025 to 12 June 2031
- Title
- Multifrequency Bioimpedance in the Early Detection of Lymphoedema
- Commercial
- No
- Sublicensing
- No
- Datasets
- 6
- Files released
- 0
Datasets: NDRS Cancer Registrations; NDRS Linked Cancer Waiting Times (Treatments only); NDRS Linked HES AE; NDRS Linked HES APC; NDRS Linked HES Outpatient; NDRS National Radiotherapy Dataset (RTDS)
What changed from DARS-NIC-656836-T2J0T-v2.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Title | Multifrequency Bioimpedance in the Early Detection of Lymphoedema | |
| Start date | 2025-06-13 | |
| End date | 2031-06-12 |
Objective for processing
University of Manchester NHS Foundation Trust is requesting an extension to the data sharing agreement with NHS England to retain data that was shared by Public Health England (PHE) in 2021. The data sharing agreement was transferred to NHS Digital (now NHS England) in 2022. No further data is needed from NHS England.
Manchester University NHS Foundation Trust requires access to NHS England data for the purpose of the following clinical trial:
The original data sharing agreement was put in place with PHE for Manchester University NHS Foundation Trust (MFT) to supply PHE with NHS numbers, dates of birth and Study IDs for participants which enabled PHE to provide data from the Office of National Statistics (ONS), National Cancer Registration and Analysis Service (NCRAS), Multiple Index Deprivation Domain (MIDD) and Hospital Episode Statistics (HES) via Public Health England. Data from these databases included information on the admissions to hospital for surgery, the type of operation, cancer treatment, other comorbidities, date of death, and socioeconomic status. The data was returned and is stored in pseudonymised format. The data allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. The BEA trial was an NIHR funded study and the data from the study needs to be retained for 10 years from the study end date. The BEA data has been merged with the data supplied by PHE and cannot be deleted until the end of the retention period.
Multifrequency Bioimpedance in the Early Detection of Lymphoedema.
Datasets received previously are:
The primary aim of the trail is to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial and to improve survival and reduce unwarranted variations in care for future breast cancer patients.
The BEA trial was an National Institute for Health and Care Research (NIHR) funded study and the data from the study needs to be retained for 10 years from the study end date.
The trial is now complete. Medicines and Healthcare products Regulatory Agency (MHRA) guidance stipulates that clinical trials should retain data for 15 years post trial.
Manchester University NHS Foundation Trust would like to retain this Data to ensure reconstruction of the trial analysis is possible if required.
No additional data will be requested from NHS England.
This Data Sharing Agreement (DSA) permits processing of the Data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Manchester University NHS Foundation Trust contact via the publishing journal or an open letter. In such circumstances, Manchester University NHS Foundation Trust may repeat the previously analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.
Manchester University NHS Foundation Trust may not undertake different analyses to those undertaken during the original analysis.
This DSA does not permit any onward sharing of the Data with the exception that the Data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA maintains a list of all clinical trials registered with them and reserve the right to audit the trial at any point from when the trial is opened to 5-year post trial closure.
A sponsoring organisation and/or the controller itself may also exercise the right to audit.
This DSA permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, Manchester University NHS Foundation Trust must confirm destruction to NHS England.
If any further data processing is required in addition to the above purposes or if the Data needs to be moved to a different location/organisation Manchester University NHS Foundation Trust must submit an Amendment request to NHS England before Data is accessed.
Data from the following NHS England Data will be retained:
[6 paragraphs unchanged]
No further data sets are required. Retention of BEA data is required which includes reoccurrence and death from breast cancer, ethnicity and socioeconomic status.
The level of Data being retained will be:
It was assessed at the time of the CAG application that the data provided to PHE was the minimum identifiable information necessary to perform the data linkage. PHE returned the data in pseudonymised format.
· Pseudonymised
Manchester University NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The Data was minimised as follows:
- Limited to the fields defined in the “DARS-NIC-656836-T2J0T-v0.2 - DATA DICTIONARY 14052020" which can be found in the supporting documents
Manchester University NHS Trust is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
University of Manchester was previously listed as a data processor in the previous iteration of this agreement but has no more involvement under the current agreement.
[1 paragraph unchanged]
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.
controller
Article 9(2)(h) - “processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Domestic Law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in
The lawful basis for processing special category data under the UK GDPR is:
paragraph 3”.
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.
[1 paragraph unchanged]
The University of Manchester is a processor acting under the instructions of Manchester University NHS Foundation Trust. The University of Manchester role is limited to analysing the data within the scope of this agreement.
Data under this DSA will be accessed by substantive employees of the organisations named as controller or processor.
Prior to the data linkage occurring, the Chief Investigator applied for Section 251 support to share identifiable data with PHE for PHE to return clinical outcome and socioeconomic data on the participants who were enrolled in the BEA study. As part of preparation for the application, the proposal was reviewed by a PPIE focus group which involved 3 cancer patients and a variety of staff members such as nurses, doctors, trials coordinators etc. The PPIE group did not see an issue with the data linkage occurring with the understanding that the data provided was pseudonymised following the linkage, would be stored in a secure location and only accessed by staff trained in data protection.
Processing activities
No
further
data will flow
into
to
NHS
England.
England for the purposes of this Data Sharing Agreement (DSA).
No further data will flow out of NHS England as this agreement is only to extend the current DSA. Previously NHS England data provided the relevant records from the Cancer Registrations, CWT, HES AE, HES APC, HES OP and RTDS datasets to Manchester University NHS Foundation Trust. The data contained no direct identifying data items but contained a unique person ID which can be used to link the BAE and NDRS datasets together.
Manchester University NHS Foundation Trust holds the relevant records from the:
The University of Manchester will return the BEA study data to the controller, Manchester University NHS Foundation Trust, for retention purposes. The BEA study data incorporates the pseudonymised data supplied by PHE (now NHS England).
- NDRS Cancer Registrations,
The data will not be backed-up at another location.
- NDRS linked Cancer Waiting Times (CWT),
The data will not leave the England/Wales at any time.
- NDRS linked HES Accident and Emergency (HES AE),
There are no specific plans to grant access to the data outside of these organisations (Manchester University NHS Foundation Trust and The University of Manchester), however, as part of the Health Research Authority’s Make it Public campaign, there is an expectation for study data collected as part of research in the NHS to be shared for future studies. If a request to provide study data is received, Manchester University NHS Foundation Trust will contact NHS England for guidance on amendments to the data sharing agreement that may be needed.
- NDRS linked HES Admitted Patient Care (HES APC),
Manchester University NHS Foundation Trust staff are required to undertake annual training on their duty of confidentiality and data protection, and responsibilities are written into the employees’ contracts. Manchester University NHS Foundation Trust has a data processing agreement in place with The University of Manchester which specifies that the data process will ensure staff are trained in the laws relating to handling personal data. The data stored at The University of Manchester is on the Data Safe Haven. Staff members permitted to use the Data Safe Haven are required to undertake annual training in confidentiality and data protection.
- NDRS linked HES outpatient (HES OP),
No further data linkage will take place.
- NDRS National Radiotherapy Dataset (RTDS).
The data supplied by Public Health England was supplied in pseudonymised format and is stored in the data safe haven at The University of Manchester as part of the BEA study data.
The Data will contain no direct identifying data items. The Data is pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.
Individual patients will not be identified in any publishing of results. Only aggregated outputs will be published with the relevant small number suppression rules applied to minimise the risk of individuals being identified.
No additional data will be disseminated by NHS England for the purposes of this DSA.
The data supplied by Public Health England was supplied in pseudonymised format will be analysed as part of the BEA study data to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death.
This DSA permits processing of the Data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
This DSA does not permit any onward sharing of the Data with the exception that the Data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA)
The Data will be stored on servers at Manchester University NHS Foundation Trust
In the event that the Data needs to be accessed for the purposes of audit or to enable verification of previous findings, the dataset would be transferred back to the Manchester University NHS Foundation Trust servers with authorisation from the Principal Investigator where it can be accessed by the study statistician only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.
The data may not be transferred to any other location and may only be accessed by substantive employees of Manchester University NHS Foundation Trust for the purposes described above.
This DSA is required for the following reasons;
The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit;
An audit may be required during the period of this DSA. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.
Expected output
The data provided by PHE allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. A journal article will be produced as a result of this processing.
The expected outputs of the processing will be:
Study level data will be contained in the outputs. Individual patients will not be identified in any publishing of results. Only aggregated outputs will be published with the relevant small number suppression rules applied to minimise the risk of individuals being identified.
- To determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial.
The results of the study will be included in a newsletter to patients and on the MFT website.
- A journal article will be produced as a result of this processing.
The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
- Newsletter to patients (Participant newsletters)
- Publication on MFT website.
-Publications and dissemination of results through the NIHR and Association of Breast Surgeons.
[1 paragraph unchanged]
Expected measurable benefits
The data provided by
PHE
NHS England
allowed the study team to determine how socioeconomic status, obesity and diabetes
[19 words unchanged]
the aim is to improve survival and reduce unwarranted variations in care.
The CI intends to use
It is intended that
the data
will be used
in a future study to analyse the effect of radiotherapy on arm
[11 words unchanged]
done subject to regulatory approvals obtained and agreed by NHS England. The
CI
Chief investigator
will pursue a separate data sharing agreement for this purpose.
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.
[1 paragraph unchanged]
The publications and dissemination of results will lead to the proposed outputs.
It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.
Publications and dissemination of results through the NIHR, MFT website, Association of Breast Surgeons.
Benefits reported
Analysis of the outputs is in progress. Study results are yet to be published therefore there are no yielded benefits to report.
The data provided by NHS England allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. The study team have submitted the draft journal article of these results for publication; however, is not yet published. Publication is expected by end of 2025.
DARS-NIC-656836-T2J0T-v2.3 26 June 2024 to 25 June 2025
- Title
- Multifrequency Bioimpedance in the Early Detection of Lymphoedema ( ODR1819_219 )
- Commercial
- No
- Sublicensing
- No
- Datasets
- 6
- Files released
- 0
Datasets: NDRS Cancer Registrations; NDRS Linked Cancer Waiting Times (Treatments only); NDRS Linked HES AE; NDRS Linked HES APC; NDRS Linked HES Outpatient; NDRS National Radiotherapy Dataset (RTDS)
What changed from DARS-NIC-656836-T2J0T-v1.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-06-26 | |
| End date | 2025-06-25 |
Objective for processing
[14 paragraphs unchanged]
Article
Article
9(2)(h) - “processing is necessary for the purposes of preventive or occupational
[45 words unchanged]
health professional and subject to the conditions and safeguards referred to in
paragraph 3”.
paragraph 3”.
[4 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
No further data will flow out of NHS England as this agreement is only to extend the current DSA.
Previously NHS England data provided the relevant records from the Cancer Registrations, CWT, HES AE, HES APC, HES OP and RTDS datasets to Manchester University NHS Foundation Trust. The data contained no direct identifying data items but contained a unique person ID which can be used to link the BAE and NDRS datasets together.
Previously NHS England data provided the relevant records from the Cancer Registrations, CWT, HES AE, HES APC, HES OP and RTDS datasets to Manchester University NHS Foundation Trust. The data contained no direct identifying data items but contained a unique person ID which can be used to link the BAE and NDRS datasets together.
[7 paragraphs unchanged]
Individual patients will not be identified in any publishing of results. Only
the broader results of the study
aggregated outputs
will be
published.
published with the relevant small number suppression rules applied to minimise the risk of individuals being identified.
[1 paragraph unchanged]
Expected output
[1 paragraph unchanged]
Study level data will be contained in the outputs. Individual patients will not be identified in any publishing of results. Only
the broader results of the study
aggregated outputs
will be
published.
published with the relevant small number suppression rules applied to minimise the risk of individuals being identified.
[1 paragraph unchanged]
The
study
analysis
of
will be complete by June 2025. It is expected the results for
the study will be
completed before July 2024. The expected the results are to be
published
by July
later in
2025.
Expected measurable benefits
The data provided by PHE allowed the study team to determine how
[14 words unchanged]
of the analysis of the BEA trial. With this analysis, the aim
is
to improve survival and reduce unwarranted variations in care.
The CI intends to use the data in a future study to analyse the effect of radiotherapy on arm and shoulder movement symptoms and development of
lymphoedema
lymphoedema.
This will be done subject to regulatory approvals obtained and agreed by NHS England. The CI will pursue a separate data sharing agreement for this purpose.
[2 paragraphs unchanged]
Publications and dissemination of results through the NIHR, MFT website, Association of Breast
Surgeons website and the Independent Patient Cancer Voice.
Surgeons.
Benefits reported
This is as per the original application. No changes have been made.
Analysis of the outputs is in progress. Study results are yet to be published therefore there are no yielded benefits to report.
Objective for processing
University of Manchester NHS Foundation Trust is requesting an extension to the data sharing agreement with NHS England to retain data that was shared by Public Health England (PHE) in 2021. The data sharing agreement was transferred to NHS Digital (now NHS England) in 2022. No further data is needed from NHS England.
The original data sharing agreement was put in place with PHE for Manchester University NHS Foundation Trust (MFT) to supply PHE with NHS numbers, dates of birth and Study IDs for participants which enabled PHE to provide data from the Office of National Statistics (ONS), National Cancer Registration and Analysis Service (NCRAS), Multiple Index Deprivation Domain (MIDD) and Hospital Episode Statistics (HES) via Public Health England. Data from these databases included information on the admissions to hospital for surgery, the type of operation, cancer treatment, other comorbidities, date of death, and socioeconomic status. The data was returned and is stored in pseudonymised format. The data allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. The BEA trial was an NIHR funded study and the data from the study needs to be retained for 10 years from the study end date. The BEA data has been merged with the data supplied by PHE and cannot be deleted until the end of the retention period.
Datasets received previously are:
- NDRS Cancer Registrations,
- NDRS linked Cancer Waiting Times (CWT),
- NDRS linked HES Accident and Emergency (HES AE),
- NDRS linked HES Admitted Patient Care (HES APC),
- NDRS linked HES outpatient (HES OP),
- NDRS National Radiotherapy Dataset (RTDS).
No further data sets are required. Retention of BEA data is required which includes reoccurrence and death from breast cancer, ethnicity and socioeconomic status.
It was assessed at the time of the CAG application that the data provided to PHE was the minimum identifiable information necessary to perform the data linkage. PHE returned the data in pseudonymised format.
Manchester University NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
Article 9(2)(h) - “processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Domestic Law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in
paragraph 3”.
The funding is provided by National Institute for Health Research. The funding is specifically for the study described.
The University of Manchester is a processor acting under the instructions of Manchester University NHS Foundation Trust. The University of Manchester role is limited to analysing the data within the scope of this agreement.
Data under this DSA will be accessed by substantive employees of the organisations named as controller or processor.
Prior to the data linkage occurring, the Chief Investigator applied for Section 251 support to share identifiable data with PHE for PHE to return clinical outcome and socioeconomic data on the participants who were enrolled in the BEA study. As part of preparation for the application, the proposal was reviewed by a PPIE focus group which involved 3 cancer patients and a variety of staff members such as nurses, doctors, trials coordinators etc. The PPIE group did not see an issue with the data linkage occurring with the understanding that the data provided was pseudonymised following the linkage, would be stored in a secure location and only accessed by staff trained in data protection.
Expected output
The data provided by PHE allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. A journal article will be produced as a result of this processing.
Study level data will be contained in the outputs. Individual patients will not be identified in any publishing of results. Only aggregated outputs will be published with the relevant small number suppression rules applied to minimise the risk of individuals being identified.
The results of the study will be included in a newsletter to patients and on the MFT website.
The study analysis will be complete by June 2025. It is expected the results for the study will be published later in 2025.
Benefits reported
Analysis of the outputs is in progress. Study results are yet to be published therefore there are no yielded benefits to report.
DARS-NIC-656836-T2J0T-v1.4 26 June 2023 to 25 June 2024
- Title
- Multifrequency Bioimpedance in the Early Detection of Lymphoedema ( ODR1819_219 )
- Commercial
- No
- Sublicensing
- No
- Datasets
- 6
- Files released
- 0
Datasets: NDRS Cancer Registrations; NDRS Linked Cancer Waiting Times (Treatments only); NDRS Linked HES AE; NDRS Linked HES APC; NDRS Linked HES Outpatient; NDRS National Radiotherapy Dataset (RTDS)
Objective for processing
University of Manchester NHS Foundation Trust is requesting an extension to the data sharing agreement with NHS England to retain data that was shared by Public Health England (PHE) in 2021. The data sharing agreement was transferred to NHS Digital (now NHS England) in 2022. No further data is needed from NHS England.
The original data sharing agreement was put in place with PHE for Manchester University NHS Foundation Trust (MFT) to supply PHE with NHS numbers, dates of birth and Study IDs for participants which enabled PHE to provide data from the Office of National Statistics (ONS), National Cancer Registration and Analysis Service (NCRAS), Multiple Index Deprivation Domain (MIDD) and Hospital Episode Statistics (HES) via Public Health England. Data from these databases included information on the admissions to hospital for surgery, the type of operation, cancer treatment, other comorbidities, date of death, and socioeconomic status. The data was returned and is stored in pseudonymised format. The data allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. The BEA trial was an NIHR funded study and the data from the study needs to be retained for 10 years from the study end date. The BEA data has been merged with the data supplied by PHE and cannot be deleted until the end of the retention period.
Datasets received previously are:
- NDRS Cancer Registrations,
- NDRS linked Cancer Waiting Times (CWT),
- NDRS linked HES Accident and Emergency (HES AE),
- NDRS linked HES Admitted Patient Care (HES APC),
- NDRS linked HES outpatient (HES OP),
- NDRS National Radiotherapy Dataset (RTDS).
No further data sets are required. Retention of BEA data is required which includes reoccurrence and death from breast cancer, ethnicity and socioeconomic status.
It was assessed at the time of the CAG application that the data provided to PHE was the minimum identifiable information necessary to perform the data linkage. PHE returned the data in pseudonymised format.
Manchester University NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
Article 9(2)(h) - “processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Domestic Law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3”.
The funding is provided by National Institute for Health Research. The funding is specifically for the study described.
The University of Manchester is a processor acting under the instructions of Manchester University NHS Foundation Trust. The University of Manchester role is limited to analysing the data within the scope of this agreement.
Data under this DSA will be accessed by substantive employees of the organisations named as controller or processor.
Prior to the data linkage occurring, the Chief Investigator applied for Section 251 support to share identifiable data with PHE for PHE to return clinical outcome and socioeconomic data on the participants who were enrolled in the BEA study. As part of preparation for the application, the proposal was reviewed by a PPIE focus group which involved 3 cancer patients and a variety of staff members such as nurses, doctors, trials coordinators etc. The PPIE group did not see an issue with the data linkage occurring with the understanding that the data provided was pseudonymised following the linkage, would be stored in a secure location and only accessed by staff trained in data protection.
Expected output
The data provided by PHE allowed the study team to determine how socioeconomic status, obesity and diabetes relate to breast cancer recurrence and death as part of the analysis of the BEA trial. A journal article will be produced as a result of this processing.
Study level data will be contained in the outputs. Individual patients will not be identified in any publishing of results. Only the broader results of the study will be published.
The results of the study will be included in a newsletter to patients and on the MFT website.
The analysis of the study will be completed before July 2024. The expected the results are to be published by July 2025.
Benefits reported
This is as per the original application. No changes have been made.
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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October 2023 —
first listed. 1 version: DARS-NIC-656836-T2J0T-v1.4
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July 2024
1 version added: DARS-NIC-656836-T2J0T-v2.3
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August 2025
1 version added: DARS-NIC-656836-T2J0T-v3.5
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-656836-T2J0T, “Multifrequency Bioimpedance in the Early Detection of Lymphoedema”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-656836-t2j0t/ (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-656836-T2J0T to see the original rows.