Long term follow-up of the UK NCRI RAPID clinical trial in early stage Hodgkin lymphoma with a particular focus on overall survival and late consequences of treatment.
The University of Manchester · Academic
In term In term in the September 2026 edition: the latest version runs to 5 May 2027.
- Reference
- DARS-NIC-597255-J9M1H
- Current version
- v2.3
- Term of current version
- 22 May 2026 to 5 May 2027
- Start date
- 6 May 2024
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 3
Data controllers
Why the data was released
Objective for processing
The Christie NHS Foundation Trust requires access to NHS England Data for the purpose of the following Clinical trial:
A Randomised Phase III Trial to Determine the Role of FDGPET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (FDG-PET Study): RAPID
The following is a summary of the aims of the research project provided on behalf of The Christie NHS Foundation Trust:
Hodgkin lymphoma is a potentially curable cancer with a median age at presentation of 29 years. Standard of care treatment for early-stage disease comprises 3-4 cycles of chemotherapy (CT) followed by radiotherapy (RT) to previously involved sites of disease. This is highly effective, but radiotherapy is known to increase the risk of second cancers and cardiovascular disease both of which undermine the quality and duration of survival. In an effort to reduce the incidence of RT related second cancers and cardiovascular disease, the UK NCRI RAPID trial compared standard treatment (CT+RT) with an experimental approach using CT alone in patients who became PET scan negative after 3 cycles of CT. Results published in the New England Journal of Medicine 2015 showed that disease control in PET negative trial participants receiving CT alone was almost as good as for those receiving CT+RT.
The initial results of RAPID are very encouraging but the second cancer and cardiovascular complications of RT take several years to manifest, and it is for this reason that long term follow up of the trial population is required. This point was also made by an editorial accompanying the New England Journal of Medicine publication. Unfortunately, many trial participants have now been discharged from hospital care and trial sites have re-focused their limited resources on other projects so new ways of accessing second cancer, cardiovascular and survival data for the RAPID population are required. It is for this reason that the study team are applying to NHS England to access Cancer Registry (for survival and 2nd cancer data) and, in parallel, the National Institute for Cardiovascular Outcomes Research (NICOR) for cardiovascular outcomes data (which is not a part of this Data Sharing Agreement). This proposal was submitted to Health Data Research UK (HDRUK) in 2020 and selected as a national exemplar.
The following NHS England Data will be accessed:
RAPID compared two different types of treatment, chemotherapy alone or chemotherapy plus radiotherapy and is now in long term follow up until 2028. In order to inform future treatment approaches nationally and internationally the study wishes to compare the late consequences of the two different treatments used in RAPID on survival, and incidence of cardiovascular disease, second cancers and other complications.
• Civil Registrations of Death – necessary because vital status is required to determine the impact of the different treatments used in the RAPID trial on survival. Cause of death is required to determine the impact of different treatments on cause of death. This request will provide information about RAPID trial patient survival, date and cause of death.
• Cancer Registration – necessary because the site of a second cancer and its date of diagnosis will determine whether or not it was likely to be related to radiotherapy. This request will provide information about all cancer diagnoses in the cohort so that a comparison of incidence and cancer type between the two treatment arms in RAPID can be performed.
DATA MINIMISATION
• Limited to data for a study cohort of approximately 500 patients who met the inclusion criteria (aged between 16 and 65 years who were recruited to the RAPID trial 2003-2010)
• Limited to data being provided once in approximately early 2024. Latest available at the time of dissemination.
The Christie 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 Christie NHS Foundation Trust have no access to NHS England Data listed in this DSA.
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 study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. National Data Opt-Outs will be upheld for the cohort.
This processing is in the public interest because the study hopes to change the management of early-stage Hodgkin lymphoma with its findings, reducing the duration and cost of treatment for Hodgkin lymphoma itself and reduce costs associated with managing these late consequences of treatment allowing re-deployment of resources elsewhere in the healthcare economy both in the UK and internationally.
The funding is provided by a private donor affiliated with The University of Manchester. The funding is specifically for the study's outcomes data analysis as described above. The Controller has confirmed to NHS England that the donor has no say in the way the study has been conducted or its purpose, no access to NHS England data, and has no ability to suppress the reporting of outcomes from this study.
University College London (UCL) is a Processor acting under the instructions of The Christie NHS Foundation Trust.
Processing activities
The UCL Cancer Trials Centre will securely transfer a cohort of approximately 500 individuals from the RAPID Trial to NHS England. The cohort file will consist of a specific set of individual participant's identifiers (specifically NHS Number, Date of Birth, and a unique person ID called a Study ID) in order for NHS England to link and extract the required data files from their data sets.
NHS England will then remove all RAPID participants who have registered a National Data Opt-Out.
NHS England Data will securely transfer the relevant record-level Data files with the study ID remaining for linkage purposes from the Civil Registrations of Death and Cancer Registration Data datasets to UCL Cancer Trials Centre.
NHS England Data will be securely stored on UCL servers for data analysis by authorised personnel. Access to confidential patient identifiable record-level NHS England Data is restricted to employees or agents of University College London. All personnel accessing the data have been appropriately trained in data protection and confidentiality.
The Data will be accessed by authorised personnel via remote access. The Data will remain on the servers at UCL at all times. Access is restricted to employees or agents of UCL authorised by the study Chair.
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 stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections 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 Data Security Protection Toolkit (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy.
The above applies in addition to any condition set out elsewhere within the DSA.
The NHS England Data will be linked with cardiovascular outcomes data from the National Institute for Cardiovascular Outcomes Research (NICOR) requested under another Data Sharing Agreement between the Controller and NICOR.
The NHS England Data will not leave England at any time.
Expected output
The expected outputs of the processing will be:
• A report of findings for dissemination to trial participants and offer to present results at Lymphoma Action's annual conference where previously there has been great interest in the late consequences of treatment for curable lymphomas.
• Presentations at relevant international meetings in 2024 (selected from American Society of Clinical Oncology, May 2024, European Haematology Association meeting June 2024, International Symposium on Hodgkin lymphoma, October 2024, American Society of Haematology, December 2024).
• A paper describing results will be submitted to relevant high impact journals (New England Journal of Medicine (NEJM), Journal of Clinical Oncology, Lancet) in 2024/2025.
The outputs 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:
• Article in Lymphoma Action magazine “Lymphoma Matters” 2024
• UCL and CRUK Cancer Trials Centre website, 2024
• HDR-UK website, 2024
Expected measurable benefits
If, because of this study, it is found that a reduced incidence of second cancers and cardiovascular disease in patients who did not receive RT in the RAPID trial this is hoped to be a major benefit for patients and hopes to change the management of early-stage Hodgkin lymphoma both in the UK and internationally.
These changes also hope to reduce the duration and cost of treatment for Hodgkin lymphoma itself and reduce costs associated with managing these late consequences of treatment allowing re-deployment of resources elsewhere in the healthcare economy.
Benefits reported so far
Not stated in the register.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Cancer Registration Data | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Civil Registrations of Death | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
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 applied to all 3 files released under this agreement, across every version. About opt-outs
No files recorded as released under the current version. 3 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-597255-J9M1H-v2.3 22 May 2026 to 5 May 2027
- Title
- Long term follow-up of the UK NCRI RAPID clinical trial in early stage Hodgkin lymphoma with a particular focus on overall survival and late consequences of treatment.
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Cancer Registration Data; Civil Registrations of Death
What changed from DARS-NIC-597255-J9M1H-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-05-22 | |
| End date | 2027-05-05 |
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
DARS-NIC-597255-J9M1H-v1.2 25 October 2024 to 5 May 2026
- Title
- Long term follow-up of the UK NCRI RAPID clinical trial in early stage Hodgkin lymphoma with a particular focus on overall survival and late consequences of treatment.
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 1
Datasets: Cancer Registration Data; Civil Registrations of Death
What changed from DARS-NIC-597255-J9M1H-v0.8
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-10-25 | |
| Cancer Registration Data: sensitivity | Sensitive |
Benefits reported
Stated in the previous version and removed here.
Yielded Benefits is not a requirement for new applications.
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
Objective for processing
The Christie NHS Foundation Trust requires access to NHS England Data for the purpose of the following Clinical trial:
A Randomised Phase III Trial to Determine the Role of FDGPET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (FDG-PET Study): RAPID
The following is a summary of the aims of the research project provided on behalf of The Christie NHS Foundation Trust:
Hodgkin lymphoma is a potentially curable cancer with a median age at presentation of 29 years. Standard of care treatment for early-stage disease comprises 3-4 cycles of chemotherapy (CT) followed by radiotherapy (RT) to previously involved sites of disease. This is highly effective, but radiotherapy is known to increase the risk of second cancers and cardiovascular disease both of which undermine the quality and duration of survival. In an effort to reduce the incidence of RT related second cancers and cardiovascular disease, the UK NCRI RAPID trial compared standard treatment (CT+RT) with an experimental approach using CT alone in patients who became PET scan negative after 3 cycles of CT. Results published in the New England Journal of Medicine 2015 showed that disease control in PET negative trial participants receiving CT alone was almost as good as for those receiving CT+RT.
The initial results of RAPID are very encouraging but the second cancer and cardiovascular complications of RT take several years to manifest, and it is for this reason that long term follow up of the trial population is required. This point was also made by an editorial accompanying the New England Journal of Medicine publication. Unfortunately, many trial participants have now been discharged from hospital care and trial sites have re-focused their limited resources on other projects so new ways of accessing second cancer, cardiovascular and survival data for the RAPID population are required. It is for this reason that the study team are applying to NHS England to access Cancer Registry (for survival and 2nd cancer data) and, in parallel, the National Institute for Cardiovascular Outcomes Research (NICOR) for cardiovascular outcomes data (which is not a part of this Data Sharing Agreement). This proposal was submitted to Health Data Research UK (HDRUK) in 2020 and selected as a national exemplar.
The following NHS England Data will be accessed:
RAPID compared two different types of treatment, chemotherapy alone or chemotherapy plus radiotherapy and is now in long term follow up until 2028. In order to inform future treatment approaches nationally and internationally the study wishes to compare the late consequences of the two different treatments used in RAPID on survival, and incidence of cardiovascular disease, second cancers and other complications.
• Civil Registrations of Death – necessary because vital status is required to determine the impact of the different treatments used in the RAPID trial on survival. Cause of death is required to determine the impact of different treatments on cause of death. This request will provide information about RAPID trial patient survival, date and cause of death.
• Cancer Registration – necessary because the site of a second cancer and its date of diagnosis will determine whether or not it was likely to be related to radiotherapy. This request will provide information about all cancer diagnoses in the cohort so that a comparison of incidence and cancer type between the two treatment arms in RAPID can be performed.
DATA MINIMISATION
• Limited to data for a study cohort of approximately 500 patients who met the inclusion criteria (aged between 16 and 65 years who were recruited to the RAPID trial 2003-2010)
• Limited to data being provided once in approximately early 2024. Latest available at the time of dissemination.
The Christie 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 Christie NHS Foundation Trust have no access to NHS England Data listed in this DSA.
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 study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. National Data Opt-Outs will be upheld for the cohort.
This processing is in the public interest because the study hopes to change the management of early-stage Hodgkin lymphoma with its findings, reducing the duration and cost of treatment for Hodgkin lymphoma itself and reduce costs associated with managing these late consequences of treatment allowing re-deployment of resources elsewhere in the healthcare economy both in the UK and internationally.
The funding is provided by a private donor affiliated with The University of Manchester. The funding is specifically for the study's outcomes data analysis as described above. The Controller has confirmed to NHS England that the donor has no say in the way the study has been conducted or its purpose, no access to NHS England data, and has no ability to suppress the reporting of outcomes from this study.
University College London (UCL) is a Processor acting under the instructions of The Christie NHS Foundation Trust.
Expected output
The expected outputs of the processing will be:
• A report of findings for dissemination to trial participants and offer to present results at Lymphoma Action's annual conference where previously there has been great interest in the late consequences of treatment for curable lymphomas.
• Presentations at relevant international meetings in 2024 (selected from American Society of Clinical Oncology, May 2024, European Haematology Association meeting June 2024, International Symposium on Hodgkin lymphoma, October 2024, American Society of Haematology, December 2024).
• A paper describing results will be submitted to relevant high impact journals (New England Journal of Medicine (NEJM), Journal of Clinical Oncology, Lancet) in 2024/2025.
The outputs 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:
• Article in Lymphoma Action magazine “Lymphoma Matters” 2024
• UCL and CRUK Cancer Trials Centre website, 2024
• HDR-UK website, 2024
DARS-NIC-597255-J9M1H-v0.8 6 May 2024 to 5 May 2026
- Title
- Long term follow-up of the UK NCRI RAPID clinical trial in early stage Hodgkin lymphoma with a particular focus on overall survival and late consequences of treatment.
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 2
Datasets: Cancer Registration Data; Civil Registrations of Death
Objective for processing
The Christie NHS Foundation Trust requires access to NHS England Data for the purpose of the following Clinical trial:
A Randomised Phase III Trial to Determine the Role of FDGPET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (FDG-PET Study): RAPID
The following is a summary of the aims of the research project provided on behalf of The Christie NHS Foundation Trust:
Hodgkin lymphoma is a potentially curable cancer with a median age at presentation of 29 years. Standard of care treatment for early-stage disease comprises 3-4 cycles of chemotherapy (CT) followed by radiotherapy (RT) to previously involved sites of disease. This is highly effective, but radiotherapy is known to increase the risk of second cancers and cardiovascular disease both of which undermine the quality and duration of survival. In an effort to reduce the incidence of RT related second cancers and cardiovascular disease, the UK NCRI RAPID trial compared standard treatment (CT+RT) with an experimental approach using CT alone in patients who became PET scan negative after 3 cycles of CT. Results published in the New England Journal of Medicine 2015 showed that disease control in PET negative trial participants receiving CT alone was almost as good as for those receiving CT+RT.
The initial results of RAPID are very encouraging but the second cancer and cardiovascular complications of RT take several years to manifest, and it is for this reason that long term follow up of the trial population is required. This point was also made by an editorial accompanying the New England Journal of Medicine publication. Unfortunately, many trial participants have now been discharged from hospital care and trial sites have re-focused their limited resources on other projects so new ways of accessing second cancer, cardiovascular and survival data for the RAPID population are required. It is for this reason that the study team are applying to NHS England to access Cancer Registry (for survival and 2nd cancer data) and, in parallel, the National Institute for Cardiovascular Outcomes Research (NICOR) for cardiovascular outcomes data (which is not a part of this Data Sharing Agreement). This proposal was submitted to Health Data Research UK (HDRUK) in 2020 and selected as a national exemplar.
The following NHS England Data will be accessed:
RAPID compared two different types of treatment, chemotherapy alone or chemotherapy plus radiotherapy and is now in long term follow up until 2028. In order to inform future treatment approaches nationally and internationally the study wishes to compare the late consequences of the two different treatments used in RAPID on survival, and incidence of cardiovascular disease, second cancers and other complications.
• Civil Registrations of Death – necessary because vital status is required to determine the impact of the different treatments used in the RAPID trial on survival. Cause of death is required to determine the impact of different treatments on cause of death. This request will provide information about RAPID trial patient survival, date and cause of death.
• Cancer Registration – necessary because the site of a second cancer and its date of diagnosis will determine whether or not it was likely to be related to radiotherapy. This request will provide information about all cancer diagnoses in the cohort so that a comparison of incidence and cancer type between the two treatment arms in RAPID can be performed.
DATA MINIMISATION
• Limited to data for a study cohort of approximately 500 patients who met the inclusion criteria (aged between 16 and 65 years who were recruited to the RAPID trial 2003-2010)
• Limited to data being provided once in approximately early 2024. Latest available at the time of dissemination.
The Christie 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 Christie NHS Foundation Trust have no access to NHS England Data listed in this DSA.
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 study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. National Data Opt-Outs will be upheld for the cohort.
This processing is in the public interest because the study hopes to change the management of early-stage Hodgkin lymphoma with its findings, reducing the duration and cost of treatment for Hodgkin lymphoma itself and reduce costs associated with managing these late consequences of treatment allowing re-deployment of resources elsewhere in the healthcare economy both in the UK and internationally.
The funding is provided by a private donor affiliated with The University of Manchester. The funding is specifically for the study's outcomes data analysis as described above. The Controller has confirmed to NHS England that the donor has no say in the way the study has been conducted or its purpose, no access to NHS England data, and has no ability to suppress the reporting of outcomes from this study.
University College London (UCL) is a Processor acting under the instructions of The Christie NHS Foundation Trust.
Expected output
The expected outputs of the processing will be:
• A report of findings for dissemination to trial participants and offer to present results at Lymphoma Action's annual conference where previously there has been great interest in the late consequences of treatment for curable lymphomas.
• Presentations at relevant international meetings in 2024 (selected from American Society of Clinical Oncology, May 2024, European Haematology Association meeting June 2024, International Symposium on Hodgkin lymphoma, October 2024, American Society of Haematology, December 2024).
• A paper describing results will be submitted to relevant high impact journals (New England Journal of Medicine (NEJM), Journal of Clinical Oncology, Lancet) in 2024/2025.
The outputs 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:
• Article in Lymphoma Action magazine “Lymphoma Matters” 2024
• UCL and CRUK Cancer Trials Centre website, 2024
• HDR-UK website, 2024
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.
-
June 2024 —
first listed. 1 version: DARS-NIC-597255-J9M1H-v0.8
-
November 2024
1 version added: DARS-NIC-597255-J9M1H-v1.2
-
July 2026
1 version added: DARS-NIC-597255-J9M1H-v2.3
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-597255-J9M1H, “Long term follow-up of the UK NCRI RAPID clinical trial in early stage Hodgkin lymphoma with a particular focus on overall survival and late consequences of treatment.”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-597255-j9m1h/ (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-597255-J9M1H to see the original rows.