NCT03445585Recruiting
Biobank for Cholestatic Liver Diseases.
A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 9150 (estimated)
- First submitted
- 14 Feb 2017
- Start date
- 1 Jan 2017
- Primary completion date
- 31 Jan 2050
- Lead sponsor
- Mayo Clinic
- NCT number
- NCT03445585
What you commit to
- Study type: Observational
- Planned participants: 9150
- From 1 Jan 2017 to the primary completion date, 31 Jan 2050
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PSC with orthotopic liver transplantation
Other illness
- PBC or PSC patients with known and overlapping other chronic liver diseases
- History of Roux en Y
Other
- Patients unable to provide informed consent
- Prisoners and institutionalized individuals
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.