A National Study Of Breast Cancer And A Range Of Late Effects Of Hodgkin Lymphoma Treatments In Women (ODR1516_470)

The Royal Marsden NHS Foundation Trust (RMNFT) requires access to NHS England data for the purpose of the following research project:

A National Study Of Breast Cancer And A Range Of Late Effects Of Hodgkin Lymphoma Treatments In Women.

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

Secondary aims are:

1. To determine the risks of developing second cancers, other morbidity, and cause-specific mortality in relation to newer HL treatment modalities, e.g. Doxorubicin (Adriamycin), Bleomycin, Vinblastine and Dacarbazine (ABVD) chemotherapy, which have been developed over the last 15-20 years with the aim of reducing the risk of long term toxicity, and compare these with older regimens such as Mechlorethamine, Vincristine (Oncovin), Procarbazine and Prednisone (MOPP) to clarify the extent to which late effects are attenuated by the more modern treatments.

2. To extend the range of morbidities for which data are available on adverse treatment effects from older HL treatments. Although there is considerable information on the effects on cancer and cardiovascular disease in the first 25 years after treatment, there is little for many other effects and for longer periods. This is important since a wide range of body systems are damaged by HL treatment, and since HL patients are largely treated as children or young adults, effects 40 and 50 years later are still of great importance – for instance, does breast cancer risk in these women remain raised, and therefore should intensive breast screening continue, or cease, at older ages?

Civil Registration of Death:

Dates and causes of death are essential outcome variables for the proposed analyses. They are required to conduct mortality analyses assessing both all-cause and cause-specific mortality among patients treated for Hodgkin Lymphoma. Access to dates and causes of death is necessary to appropriately account for death as a competing risk in analyses of other late adverse outcomes, such as second primary cancers and late-onset cardiovascular disease.

HES APC:

This dataset is required to ascertain hospital-recorded morbidity outcomes during long-term follow-up of patients treated for Hodgkin Lymphoma. Diagnostic and procedural information is requested to enable identification of severe late-effect morbidities such as cardiovascular disease, serious infections, and other treatment-related conditions that are not reliably captured in outpatient or registry data alone.

NDRS Cancer Consolidated:

Access to Consolidated Packages 9 and 11 is required to support accurate record linkage and avoidance of duplication of patients across multiple historic datasets covering several decades of follow-up (back to the 1950s). Identifiable patient information, including core demographic and cancer registration identifiers, is necessary to reliably cross-reference individuals across datasets generated in different time periods and coding systems, and to ensure that each patient is uniquely and consistently represented. Access to these datasets is therefore necessary for long-term risk estimation for both historical and contemporary treatment approaches and is necessary to deliver the stated public health and clinical benefits of the study

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

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.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

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

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

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

The aim of this study is to enable patients and clinicians to undertake more informed consent and decision-making about the patient’s risk of long-term effects of a range of cancer treatments and therefore understand risks better, achieve greater informed consent at the point of cancer treatment, and embark on a more personalised care pathway. Such information would form a vital component of patients’ long-term “survivorship plans”, which are integrated into the NHS as a key part of patient care.

Specific benefits that have arisen since this support has been in place:

1. The setup of this study and initial results enabled the publication of detailed risk profiles of these women’s much higher long-term risk of developing breast cancer following their Lymphoma treatment. In large part as a result of the information provided from this study, a national high-risk breast cancer screening programme (in partnership with PHE - now NHS Digital - and the Christie) has been established – BARD – breast screening after radiotherapy dataset. This is facilitating the systematic invitation of women to have breast cancer screening identified as being at high risk of developing breast cancer from the cancer treatments they received, as a direct consequence of the results of this study. It is hoped that this screening will significantly mitigate the risk of breast cancer in these women and enable earlier diagnosis and treatment to improve their long-term survival.

The Royal Marsden NHS Foundation Trust (RMNFT) requires access to NHS England data for the purpose of the following research project:

A National Study Of Breast Cancer And A Range Of Late Effects Of Hodgkin Lymphoma Treatments In Women

This study was previously managed by the Institute of Cancer Research (ICR). Following the retirement of the study’s Principal Investigator (PI) the study and all data transferred to the RMNFT.

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

Secondary aims are:

1. To determine the risks of developing second cancers, other morbidity, and cause-specific mortality in relation to newer HL treatment modalities, e.g. Doxorubicin (Adriamycin), Bleomycin, Vinblastine and Dacarbazine (ABVD) chemotherapy, which have been developed over the last 15-20 years with the aim of reducing the risk of long term toxicity, and compare these with older regimens such as Mechlorethamine, Vincristine (Oncovin), Procarbazine and Prednisone (MOPP) to clarify the extent to which late effects are attenuated by the more modern treatments.

2. To extend the range of morbidities for which data are available on adverse treatment effects from older HL treatments. Although there is considerable information on the effects on cancer and cardiovascular disease in the first 25 years after treatment, there is little for many other effects and for longer periods. This is important since a wide range of body systems are damaged by HL treatment, and since HL patients are largely treated as children or young adults, effects 40 and 50 years later are still of great importance – for instance, does breast cancer risk in these women remain raised, and therefore should intensive breast screening continue, or cease, at older ages?

To support these aims the study team request permission to retain the following datasets that were previously disseminated by the Public Health England (PHE) National Cancer Registration and Analysis Service (NCRAS):

• Identifiable National Disease Registry Service (NDRS) Cancer Registration Data

• Identifiable NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Outpatient, Admitted Patient Care and Accident & Emergency subsets.

RMNFT are permitted to retain and process data until the end date of this Agreement.

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

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

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

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

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

The aim of this study is to enable patients and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term effects of a range of cancer treatments and therefore understand risks better, achieve greater informed consent at the point of cancer treatment, and embark on a more personalised care pathway. Such information would form a vital component of patients’ long-term “survivorship plans”, which are integrated into the NHS as a key part of patient care.

Specific benefits that have arisen since this support has been in place:

1. The setup of this study and initial results enabled the publication of detailed risk profiles of these women’s much higher long-term risk of developing breast cancer following their Lymphoma treatment. In large part as a result of the information provided from this study, a national high-risk breast cancer screening programme (in partnership with PHE - now NHS Digital - and the Christie) has been established – BARD – breast screening after radiotherapy dataset. This is facilitating the systematic invitation of women to have breast cancer screening identified as being at high risk of developing breast cancer from the cancer treatments they received, as a direct consequence of the results of this study. It is hoped that this screening will significantly mitigate the risk of breast cancer in these women and enable earlier diagnosis and treatment to improve their long-term survival.

The Royal Marsden NHS Foundation Trust (RMNFT) requires access to NHS England data for the purpose of the following research project:

A National Study Of Breast Cancer And A Range Of Late Effects Of Hodgkin Lymphoma Treatments In Women

This study was previously managed by the Institute of Cancer Research (ICR). Following the retirement of the study’s Principal Investigator (PI) the study and all data transferred to the RMNFT.

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

Secondary aims are:

1. To determine the risks of developing second cancers, other morbidity, and cause-specific mortality in relation to newer HL treatment modalities, e.g. Doxorubicin (Adriamycin), Bleomycin, Vinblastine and Dacarbazine (ABVD) chemotherapy, which have been developed over the last 15-20 years with the aim of reducing the risk of long term toxicity, and compare these with older regimens such as Mechlorethamine, Vincristine (Oncovin), Procarbazine and Prednisone (MOPP) to clarify the extent to which late effects are attenuated by the more modern treatments.

2. To extend the range of morbidities for which data are available on adverse treatment effects from older HL treatments. Although there is considerable information on the effects on cancer and cardiovascular disease in the first 25 years after treatment, there is little for many other effects and for longer periods. This is important since a wide range of body systems are damaged by HL treatment, and since HL patients are largely treated as children or young adults, effects 40 and 50 years later are still of great importance – for instance, does breast cancer risk in these women remain raised, and therefore should intensive breast screening continue, or cease, at older ages?

To support these aims the study team request permission to retain the following datasets that were previously disseminated by the Public Health England (PHE) National Cancer Registration and Analysis Service (NCRAS):

• Identifiable National Disease Registry Service (NDRS) Cancer Registration Data

• Identifiable NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Outpatient, Admitted Patient Care and Accident & Emergency subsets.

RMNFT are permitted to retain and process data until the end date of this Agreement.

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

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

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

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

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

The aim of this study is to enable patients and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term effects of a range of cancer treatments and therefore understand risks better, achieve greater informed consent at the point of cancer treatment, and embark on a more personalised care pathway. Such information would form a vital component of patients’ long-term “survivorship plans”, which are integrated into the NHS as a key part of patient care.

Specific benefits that have arisen since this support has been in place:

1. The setup of this study and initial results enabled the publication of detailed risk profiles of these women’s much higher long-term risk of developing breast cancer following their Lymphoma treatment. In large part as a result of the information provided from this study, a national high-risk breast cancer screening programme (in partnership with PHE - now NHS Digital - and the Christie) has been established – BARD – breast screening after radiotherapy dataset. This is facilitating the systematic invitation of women to have breast cancer screening identified as being at high risk of developing breast cancer from the cancer treatments they received, as a direct consequence of the results of this study. It is hoped that this screening will significantly mitigate the risk of breast cancer in these women and enable earlier diagnosis and treatment to improve their long-term survival.

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

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

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

Secondary aims are:

1. To determine the risks of developing second cancers, other morbidity, and cause-specific mortality in relation to newer HL treatment modalities, e.g. Doxorubicin (Adriamycin), Bleomycin, Vinblastine and Dacarbazine (ABVD) chemotherapy, which have been developed over the last 15-20 years with the aim of reducing the risk of long term toxicity, and compare these with older regimens such as Mechlorethamine, Vincristine (Oncovin), Procarbazine and Prednisone (MOPP) to clarify the extent to which late effects are attenuated by the more modern treatments.

2. To extend the range of morbidities for which data are available on adverse treatment effects from older HL treatments. Although there is considerable information on the effects on cancer and cardiovascular disease in the first 25 years after treatment, there is little for many other effects and for longer periods. This is important since a wide range of body systems are damaged by HL treatment, and since HL patients are largely treated as children or young adults, effects 40 and 50 years later are still of great importance – for instance, does breast cancer risk in these women remain raised, and therefore should intensive breast screening continue, or cease, at older ages?

To support these aims the study team request permission to retain the following datasets that were previously disseminated by the Public Health England (PHE) National Cancer Registration and Analysis Service (NCRAS):

• Identifiable National Disease Registry Service (NDRS) Cancer Registration Data

• Identifiable NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Outpatient, Admitted Patient Care and Accident & Emergency subsets.

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

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

The lawful basis for this processing falls under the UK General Data Protection Regulation (GDPR) Article 6(1)(e), the processing is necessary for the performance of a task in the public interest. The study processes sensitive health information for the purposes of scientific research with appropriate safeguards in place to protect personal information. The processing of special category data falls under UK GDPR Article 9(2)(j), the processing is necessary for scientific research, in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject). The data are required for research purposes in the public interest - meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data.

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

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

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

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

The aim of this study is to enable patients and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term effects of a range of cancer treatments and therefore understand risks better, achieve greater informed consent at the point of cancer treatment, and embark on a more personalised care pathway. Such information would form a vital component of patients’ long-term “survivorship plans”, which are integrated into the NHS as a key part of patient care.

Specific benefits that have arisen since this support has been in place:

1. The setup of this study and initial results enabled the publication of detailed risk profiles of these women’s much higher long-term risk of developing breast cancer following their Lymphoma treatment. In large part as a result of the information provided from this study, a national high-risk breast cancer screening programme (in partnership with PHE - now NHS Digital - and the Christie) has been established – BARD – breast screening after radiotherapy dataset. This is facilitating the systematic invitation of women to have breast cancer screening identified as being at high risk of developing breast cancer from the cancer treatments they received, as a direct consequence of the results of this study. It is hoped that this screening will significantly mitigate the risk of breast cancer in these women and enable earlier diagnosis and treatment to improve their long-term survival.