Checkpoint inhibitor-induced liver injury study
Research type
Research Study
Full title
Checkpoint inhibitor-induced liver injury (ChILI) study
IRAS ID
274603
Contact name
Guru Aithal
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
3 years, 0 months, days
Research summary
• Immune checkpoint inhibitors are proven cancer treatment drugs which have evolved over the last decade and improved outcomes in various cancers.
• They work to boost the normal immune system by restoring processes which get blocked when cancer develops.
• These drugs boost all the immune cells, not just the ones that can attack the cancer.
• The overactive immune system following this treatment can damage the liver and other organs which can be serious. These injuries are unpredictable and difficult to treat.• Our aim is to develop new tests that can identify, predict and prevent checkpoint inhibitor-induced liver injury (ChILI) and identify the risk factors for developing this condition.
• Patients with cancer who are about to start checkpoint inhibitors by oncologist or developed liver injury following the treatment will be eligible for the study.
• The study will be conducted at Nottingham University Hospitals (Queens medical Centre and Nottingham City Hospital) and St George's University Hospitals NHS Foundation Trust.
• The study will run for 3 years.
• For participants starting on check point inhibitors, we plan to see them twice (before treatment and 6- 14 weeks after).
• For participants who developed liver injury they will be seen three times over 1 month (at time of reaction, 1 week after and 1 month after).
• Each research visit will last around 30 minutes which involved taking medical history including medication history and collection of up to 80 mls of blood (4½ tablespoons) and a urine and/or stool (‘poo’) sample (urine and stool samples are optional). We will obtain consent for liver sample only if liver biopsy was clinically indicated.
• Visits will be adapted to coincide with routine hospital care and clinic visits whenever possible and samples for research will be collected alongside clinical care blood tests.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0274
Date of REC Opinion
15 Jun 2020
REC opinion
Favourable Opinion