Biobank for Cholestatic Liver Diseases.

Launched by MAYO CLINIC · Feb 22, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Biobank for Cholestatic Liver Diseases," is focused on collecting samples and health information from patients with certain liver diseases, specifically Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cirrhosis (PBC), as well as liver cancer. The goal is to gather valuable data that researchers can use now and in the future to better understand these conditions. The study is currently looking for participants aged 18 to 85, including those diagnosed with PSC or PBC, as well as healthy individuals and those with other chronic liver diseases to serve as controls.

If you or a family member are eligible, you can expect to provide samples and health information for the study. It’s important to note that women of childbearing age, including pregnant women, can participate safely. However, there are some exclusions, such as individuals with overlapping liver diseases or those unable to give consent. This trial aims to improve our understanding of liver diseases, which could lead to better treatments and outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • PSC
• • Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.
• • The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.
• • Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
• • Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
• • PBC
• • Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.
• • The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.
• • Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
• • Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
• • Controls
• • Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.
• • Liver Disease Controls
• • Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.
• Exclusion Criteria (all subjects):
• • PBC or PSC patients with known and overlapping other chronic liver diseases
• • Patients unable to provide informed consent
• • Prisoners and institutionalized individuals
• • Exclusion Criteria (for bile collection during ERCP)
• • PSC with orthotopic liver transplantation
• • History of Roux en Y