PRedicting cancer Immunotherapy Side Effects
Research type
Research Study
Full title
PRISE study:PRedicting cancer Immunotherapy Side Effects
IRAS ID
195787
Contact name
Oliver Brain
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
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Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Some cancers are able to survive and grow because the immune system fails to attack and kill these cells. In part this is due to high expression levels of immune cell (T cell) proteins called check-point inhibitors, whose natural function is to prevent over-activation of the immune system during, for example, an infection. Targeting these check-point inhibitors has now become standard therapy for the treatment of some cancers. As these drugs 'awaken' the immune system they contribute to the development of immune-mediated side-effects. The most common of these - inflammation of the gut or colitis - is of particular interest not only because it is a frequent cause of stopping the treatment, but also because it can lead to serious life-threatening complications such as gut perforation. Therefore is worth in understanding the disease process such that we can predict who is likely to get colitis, and we can improve patient safety and quality of life.
Our research aims are to investigate the cause of colitis in order that they can be better predicted and treated. All cancer patients due to receive check-point inhibitors (either singly or in combination) would be eligible to take part, and the study would take place within the OUH NHS Foundation Trust. Participants would be asked to provide blood and stool samples, and have a flexible sigmoidoscopy and biopsies at the time they develop colitis. Those who do not develop colitis by week 7 will be invited for an optional flexible sigmoidoscopy and blood/ stool samples. A flexible sigmoidoscopy is a limited endoscopic examination of the large bowel or colon that lasts 5-10 minutes. It is required for all the flexible sigmoidoscopies a phosphate enema for bowel preparation and the procedure are well-tolerated.REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0412
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion