Actively Recruiting
A Resource of Blood and Other Biospecimens from Patients With Cholestatic Liver Disease and Unaffected Individuals
Led by Mayo Clinic · Updated on 2026-02-17
9150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are creating a biobank of specimens and clinical data to help understand cholestatic liver diseases, specifically primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC). This observational study collects information to support current and future research aimed at learning how these diseases begin and progress. Participants include those diagnosed with PSC, PBC, other chronic liver diseases, and individuals without liver disease. Samples of blood, saliva, stool, and urine are collected during visits, through mail-home kits, or remote phlebotomy. Bile samples and bile duct cells are collected only during necessary clinical procedures called ERCPs at Mayo Clinic. During the study, participants provide various biological samples and clinical data. Researchers will monitor the number of participants, types of samples collected, and clinical outcomes over 20 years. This long-term observation helps develop new tests for early detection and better understanding of disease progression.
CONDITIONS
Brief Title
Biobank for Cholestatic Liver Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with primary sclerosing cholangitis (PSC) aged 18 to 85 at enrollment.
- Diagnosis of PSC based on clinical and biochemical evidence of chronic cholestasis for at least six months, positive cholangiographic findings, and compatible liver biopsies if available.
- Patients with PSC who have had liver transplantation may enroll except for bile collection.
- Women with PSC who are pregnant or of childbearing potential may enroll.
- Patients diagnosed with primary biliary cirrhosis/cholangitis (PBC) aged 18 to 85 at enrollment.
- Diagnosis of PBC based on clinical and biochemical evidence of chronic cholestasis for at least six months, positive anti-mitochondrial antibodies, and compatible liver biopsies if available.
- Patients with PBC who have had liver transplantation may enroll except for bile collection.
- Women with PBC who are pregnant or of childbearing potential may enroll.
- Controls without history of PBC, PSC, or other chronic liver disease aged 18 to 85.
- Patients with other chronic liver diseases (not PBC or PSC) aged 18 to 85.
You will not qualify if you...
- Patients with PBC or PSC who have other overlapping chronic liver diseases.
- Individuals unable to provide informed consent.
- Prisoners and institutionalized individuals.
- Patients with PSC who have had liver transplantation are excluded from bile collection during ERCP.
- Patients with history of Roux en Y procedure are excluded from bile collection during ERCP.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 years
Participants provide blood, saliva, stool, and urine samples periodically during visits or via mail-home kits and remote phlebotomy. Bile and bile duct cells are collected during clinically necessary ERCP procedures for those undergoing these procedures.
Periodic visits and mail-home or remote sample collection
Duration - Up to 20 years
Participants are observed over time to collect clinical data and monitor disease progression and outcomes.
Ongoing clinical assessments during regular healthcare visits
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
Research Team
E
Erik Schlicht, CCRP, B.A.
J
Jackie Bianchi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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