Asp-PSC
Research type
Research Study
Full title
Asp-PSC: Effect of Aspirin on Reducing Cancer & Improving Outcomes in Primary Sclerosing Cholangitis
IRAS ID
1007320
Contact name
Shahid Khan
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN12358813
Research summary
Primary Sclerosing Cholangitis (PSC) is an chronic autoimmune disease of the bile ducts and liver. PSC patients often have inflammatory bowel disease (IBD). Four out of ten people with both PSC and IBD get cancer of the bile ducts, gallbladder, liver or bowel. There are no screening strategies which reduce hepatobiliary cancers and there is no therapy shown to help slow the rate of PSC or reduce cancer risk. Based on pre-clinical, epidemiological and randomised data, aspirin may have anti-cancer effects and help reduce the PSC related cancer risk.
The main aims of the study are to investigate if daily low dose Aspirin over a minimum of 5 years versus placebo reduces cancer risk in PSC and IBD patients. We will also be looking at safety and tolerability of Aspirin and liver transplantation rates. There will be future work conducted on samples and imaging to establish if PSC related cancers can be detected.
Cancer Research UK funds this study and will be conducted across approximately 60 centres in the UK recruiting 968 patients. Patients and researchers will be blinded to the study and will not know if they receive placebo or aspirin. The treatment/intervention is Aspirin 75mg once daily (oral) and the comparator will be Placebo. The study population will be patients at least 12 months post a diagnosis of PSC-IBD, randomised at a 2:1 ratio of Aspirin vs Placebo. Participants will be followed for a minimum of 5 years. Patients will attend a screening visit, month one phone call, 6 monthly visits over 5 years , end of treatment. Follow up data will be collected yearly after 5 years for a maximum of 5 years. Urine and blood samples will be taken at the screening visit and every 6 months over 5 years. If the trial shows aspirin significantly and safely improves cancer free survival and overall survival in patients with PSC-IBD, then we anticipate this would lead to a change in standard of care treatment for these patients.
REC name
Wales REC 1
REC reference
23/WA/0282
Date of REC Opinion
24 Oct 2023
REC opinion
Further Information Favourable Opinion