Inflammatory bowel disease-associated lymphoma

The Data will be used for the purpose of a research project: Inflammatory bowel disease-associated lymphoma

Inflammatory bowel disease (IBD) is caused by an overactive immune system in the gut. There are different types of IBD. People with IBD are more likely to develop lymphoma, a serious type of blood cancer, than people without IBD. Lymphoma in patients with IBD is becoming more common. However, we don’t know which individuals with IBD are at risk of lymphoma, and why.

Several factors may cause this increased risk, including some medicines used to treat IBD. Studies have shown that some types of IBD, for example IBD which starts in childhood, have a higher risk of lymphoma. This suggests that some people with IBD genes (DNA) may be at an increased risk of lymphoma. Genes are the specific instructions for how our bodies function, which are passed down from our parents. How the genes of people with IBD affect their risk of developing lymphoma has not been examined by previous research.

This project aims to:

- identify which types of IBD carry the highest risk of developing lymphoma

- explore whether genetic factors are involved

- find out which medicines may increase the risk.

This information could be used to reduce the risk of lymphoma for IBD patients and allow for the identification of factors that increase risk of lymphoma with greater accuracy. Access to cancer data will enable accurate identification of which individuals have received a pathologically-confirmed diagnosis of lymphoma, the types of lymphoma they have had, and how they responded to treatment.

Cambridge University Hospitals NHS Foundation Trust will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Surname and Forename) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the cancer datasets to Cambridge University Hospitals NHS Foundation Trust. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

One component of the proposed study involves analysis of NIHR IBD BioResource genotype array data and whole exome sequencing data. This analysis will be undertaken by a Senior Staff Scientist at the Wellcome Sanger Institute on the Wellcome Sanger Institute’s secure data infrastructure. The analysis of cancer registry data will be used to identify which BioResource participants to include in this analysis. BioResource staff will transfer a list of pseudonymous IDs only to the Wellcome Sanger team. No cancer registry data will be transferred to the Sanger Institute’s environment.

The Data will not be transferred to any other location.

The Data will be stored on the NIHR BioResource Secure Data Environment (SDE) at Cambridge University Hospitals NHS Foundation Trust.

Cambridge University Hospitals NHS Foundation Trust stores Data on the Cloud provided by Microsoft Limited.

The Data will be accessed by authorised personnel via remote access.

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

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

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

The Data will be linked at person record level with data held within the Bioresource, containing clinical phenotypic details, genetic data and health and lifestyle information from questionnaires obtained from over 119 NHS trusts.

The expected outputs of the processing will be:

- Submissions to high-impact academic journals

- Presentations at appropriate leading national and international conferences

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:

- Journals

- Conferences

- Finding will also be disseminated to patients directly (e.g. via webinars).

There are large gaps in the current knowledge of which people with IBD are at risk and lymphoma, how medications alter this risk, and the biological mechanisms involved. This project aims to improve the ability to risk-stratify patients with IBD regarding their risk of lymphoma. This will add to the evidence base available to clinicians, the authors of guidelines and policymakers concerned with the management of this group of patients.

This project will greatly enhance understanding of the genetic factors, types of IBD and medications associated with lymphoma. By understanding who is most at risk, and which factors increase this risk, the risk of lymphoma could be reduced by modifying the medications used to treat IBD in certain individuals. This is a change that could happen quickly.

Results of these analyses would likely be considered by the authors of national and international guidelines regarding the management of IBD if the data shows significant patient groups who would benefit from modified treatment protocols/precision medicine.

Ultimately this research aims to reduce the number of people living with IBD who develop lymphoma.

The use of the data could:

- help the system to better understand the health and care needs of populations.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

- advance understanding of regional and national trends in health and social care needs.

- advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions

- provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

- support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Not stated in the register.