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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Noninfective enteritis and colitisMalignant neoplasms of ill-defined, secondary and unspecified sites
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Immune checkpoint inhibitors (ICPI) are drugs that release cancer immunity. ICPI cause immune attack on normal organs resulting in immune related adverse events (IrAE) including bowel inflammation called immune related colitis (IR-colitis). We will describe the clinical and pathological features of IR-colitis, exploring a role for viruses including Epstein Barr virus (EBV) which lives harmlessly in most people. More broadly, the study will explore clinical, pathological and microbiological features associated with ICPI treatment, cancer control and IrAE.
At the University Hospitals Birmingham, we will recruit fifty consenting people treated with ICPI at standard of care clinic appointments. We will take scheduled blood and body product samples before during and after treatment induction. Also, we will recruit groups of around ten consenting patients for particular experiments, requesting unscheduled samples. This may include additional tissue sampling during standard procedures or additional non-invasive biopsies. These may include people presenting with IR-colitis, treated with ICPI, with other IrAE, with cancer without ICPI treatment, with colitis for other reasons, and healthy volunteers. Samples from these groups may be used to characterise the values or variation of particular measurements to better understand their meaning in the main cohort.
Retrospective clinical data and archival pathology samples surplus to clinical need will be explored in relation to specific questions relating to ICPI treatment, IrAE and cancer control within scope of the project. In particular, we will focus on data and samples relating to previous episodes of IR-colitis, inflammatory bowel disease and EBV-lymphoproliferation and will seek evidence of reactivation of EBV and other viruses. At NHS centres in England and Wales, clinical data with linked archival tissue will be collated by clinical care teams. Fully anonymised data and material will be analysed at the University of Birmingham. Consent will not be sought for use of fully anonymised data and samples.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Clinical Laboratory Study;
You can take part if:
You may not be able to take part if:
Prospective cancer patient cohorts (i) Known to be anaemic (Haemoglobin < 100g/L unless corrected by transfusion) (ii) Illness or disorder which in the opinion of the participant or their medical practitioner makes them unsuitable to provide blood samples (iii) Known to have active Hepatitis B, hepatitis C or HIV infection (additional testing not required) Non-cancer patients (i) Known to be anaemic (Haemoglobin < 100g/L unless corrected by transfusion) (ii) Illness or disorder which in the opinion of the participant or their medical practitioner makes them unsuitable to provide blood samples (iii) Known to have active Hepatitis B, hepatitis C or HIV infection (additional testing not required) Healthy volunteers (i) Known to be anaemic (self-selected, additional testing not required) (ii) Known to have active hepatitis B, hepatitis C or HIV infection (self-selected - additional testing not required) (iii) Known cancer diagnosis (self-selected) (iv) Treated with immunosuppressive agents (e.g. steroids) for any condition (self-selected) Please note, to safeguard the privacy of staff members of UoB and UHBFT, the eligibility criteria will be set out in the recruitment email, and no face-to-face history will be taken. Healthy volunteers will, therefore, self-select for the study and sign a form to indicate they match the inclusion and exclusion criteria. No formal eligibility criteria apply to retrospective studies
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Birmingham and funded by Medical Research Council (MRC) .
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for Trial ID: CPMS 36774
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