Identifying features contributing to the development and progression of primary sclerosing cholangitis
- Conditions
- Primary sclerosing cholangitisDigestive System
- Registration Number
- ISRCTN12203379
- Lead Sponsor
- University of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 350
Eligible participants must fulfil the criteria set out below, as related to the sample type in question.Peripheral blood:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations - participants must have an established diagnosis of any of the following conditions: 5.1.PSC5.2.PBC5.3.MASLD6.IBD alone populations - participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy controls -defined as participants who do not have present or previous gastrointestinal or liver disease. Participants with functional gastrointestinal disorder (FGID) can be included. This will be clinician defined.Stool:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations: participants must have an established diagnosis of any of the following conditions: 5.1.PSC5.2.PBC5.3.MASLD6.IBD populations: participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy control populations: defined as participants who do not have present or previous gastrointestinal or liver disease. Participants with functional gastrointestinal disorder (FGID) can be included. This will be clinician defined.Colonic biopsies:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations: participants must have an established diagnosis of PSC.6.IBD population: participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy control populations:7.1.Participants without a diagnosis of PSC or IBD, attending for a colonoscopy who do not meet the exclusion criteria.Biliary aspirates/biopsies:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Established diagnosis of PSC.
Here is the revised text with the requested numbering system:Eligible participants must fulfill the criteria set out below, as related to the sample type in question.Peripheral blood:1. Liver transplant recipients.2. Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.1. Secondary sclerosing cholangitis 1.2. IgG4-related cholangitis 1.3. Viral hepatitis 1.4. Alcohol-related liver disease 1.5. Drug-induced liver disease or drug-induced sclerosing cholangitis 1.6. Hereditary haemochromatosis 1.7. Alpha-1-antitrypsin disease 1.8. Wilson disease 1.9. Budd-Chiari Syndrome *Individuals with autoimmune hepatitis, concomitant IBD, and overlapping features of sclerosing cholangitis are eligible and may be recruited to the PSC group.*3. Evidence of acute or chronic gastrointestinal disease not listed in the inclusion criteria.4. A history of malignancy within the prior 3 years, except for individuals with: 1.1. Prior gallbladder cancer, with gallbladder removal, and without evidence of recurrence or disseminated/metastatic disease. 1.2. Prior colonic cancer, with local resection, and without evidence of recurrence or disseminated/metastatic disease. 1.3. Prior non-melanomatous skin cancer that has been resected, without evidence of recurrence or disseminated/metastatic disease.5. If the potential participant is a member of the clinical site study team and/or his/her immediate family.6. Women who are pregnant or less than 12 weeks post-partum.Stool:1. Liver transplant recipients.2. Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.1. Secondary sclerosing cholangitis 1.2. IgG4-related cholangitis 1.3. Viral hepatitis 1.4. Alcohol-related liver disease 1.5. Drug-induced liver disease or drug-induced sclerosing cholangitis 1.6. Hereditary haemochromatosis 1.7. Alpha-1-antitrypsin disease 1.8. Wilson disease 1.9. Budd-Chiari Syndrome *Individuals with autoimmune hepatitis, concomitant IBD, and overlapping features of sclerosing cholangitis are eligible and may be recruited to the PSC group.*3. Evidence of acute or chronic gastrointestinal disease not listed in the inclusion criteria.4. A history of malignancy within the prior 3 years, except for individuals with: 1.1. Prior gallbladder cancer, with gallbladder removal, without evidence of recurrence or disseminated/metastatic disease. 1.2. Prior colonic cancer, with local resection, without evidence of recurrence or disseminated/metastatic disease. 1.3. Prior non-melanomatous skin cancer that has been resected, without evidence of recurrence or disseminated/metastatic disease.5. Previous colonic or small bowel resection.6. If the potential participant is a member of the clinical site study team and/or his/her immediate family.7. Women who are pregnant or less than 12 weeks post-partum.Colonic biopsies:1. Liver transplant recipients.2. Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.1. Secondary sclerosing cholangitis 1.2. IgG4-related cholangitis 1.3. Viral hepatitis 1.4. Alcohol-related liver disease 1.5. Drug-induced liver disease or drug-induced sclerosing cholangitis 1.6. Hereditary haemochromatosis 1.7. Alpha-1-antitrypsin diseas
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method