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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.
Miss
Meena
Reddi
-
m.reddi@imperial.ac.uk
Dr
Rinat
Ezra
+44 (0)20 7594 9480
r.ezra@imperial.ac.uk
Dr
Shahid
Khan
+44 (0)203 312 6454/6254
shahid.khan1@nhs.net
Primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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 treatment shown to help slow the rate of PSC or reduce cancer risk. 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 reduces cancer risk in PSC and IBD patients. The researchers will also be looking at the 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.
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:
You can take part if:
You may not be able to take part if:
1. Evidence of concomitant disease(s) that causes secondary sclerosing cholangitis2. Evidence of any of the following diseases: IgG4 related disease, PBC, acute or chronic viral hepatitis, alcohol-related liver disease, Wilson disease, Budd-Chiari syndrome, portal vein thrombosis, alpha-1-antitrypsin disease, hepatic sarcoidosis, cystic fibrosis, Progressive familial intrahepatic cholestasis (PFIC), hereditary haemochromatosis, non-alcoholic steatohepatitis (NASH) – those with simple hepatic steatosis without evidence of NASH or liver fibrosis secondary to fatty liver disease are allowed to participate, other metabolic liver disease, active malignancy in the last 5 years (except treated/excised non-melanomatous skin cancer).3. Have a previous diagnosis of colorectal cancer, cholangiocarcinoma, gallbladder cancer at any time point.4. Has received a liver transplant, has been referred for liver transplant assessment, or is listed for a liver transplant. 5. Had any of the following procedures: colonic resection of any nature, including those with a defunctioning ostomy.6. Consume more than the recommended allowance of 14 units of alcohol per week (as set out by the Department of Health).7. Current or recent participation in any other clinical trial of an investigational medicinal product (CTIMP) within the last 6 weeks prior to first dose of aspirin/placebo8. Already taking aspirin.9. History of non-variceal upper gastrointestinal (GI) bleeding within 1 year.10. A history of congestive cardiac failure.11. A known diagnosis of glucose-6 -phosphate dehydrogenase.12. Child Pugh B or C cirrhosis13. Untreated thyrotoxicosis or hypothyroidism14. Familial history of a hereditary cancer syndrome, or confirmed genetic predisposition that heightens cancer risk.15. Vaccination for varicella zoster in the six weeks prior to screening period16. Known allergy to aspirin17. A history of NSAID/ aspirin induced asthma and nasal polyps18. Concurrently taking non-steroidal anti-inflammatory drugs (NSAIDs) in the four weeks prior to screening19. History of haemophilia and/or other bleeding disorders where aspirin is contraindicated20. Taking other anti-platelet or anti-coagulant medication (e.g., clopidogrel, prasugrel, warfarin, apixaban, rivaroxaban, dabigatran or therapeutic heparin preparations)21. Active, or history of recurrent peptic ulcer 22. Patients who are suffering from gout 23. Severe renal impairment24. Taking methotrexate at a dose of >15mg/week 25. Taking selective serotonin-reuptake inhibitors
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Shahid
Khan
+44 (0)203 312 6454/6254
shahid.khan1@nhs.net
Miss
Meena
Reddi
-
m.reddi@imperial.ac.uk
Dr
Rinat
Ezra
+44 (0)20 7594 9480
r.ezra@imperial.ac.uk
The study is sponsored by Imperial College London and funded by Cancer Research UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 55190
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
