What is this study trying to find out about cholestatic liver diseases?

This study aims to improve understanding of primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC). Researchers are collecting biological samples and clinical data to learn how these diseases start and progress. This knowledge may help develop new tests to detect complications early and predict disease outcomes.

Who may be eligible for this cholestatic liver disease clinical trial?

Adults aged 18 to 85 with diagnoses of PSC, PBC, other chronic liver diseases, or no liver disease may be eligible. Both men and women can participate. Key factors include ability to provide consent and not having overlapping chronic liver diseases or institutionalization. Please review eligibility criteria for more details.

Is there any cost to participate in this cholestatic liver disease clinical trial?

Study-related care, including specimen collection and all trial visits, is provided at no cost. Personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any associated travel costs.

Actively Recruiting

Age: 18Years - 85Years

All Genders

Healthy Volunteers

ID03445585

Collection of Blood and Other Samples from Adults With Cholestatic Liver Diseases and Healthy Volunteers Including Primary Biliary CirrhosisCholangitis and Primary Sclerosing Cholangitis

Led by Mayo Clinic · Updated on 2026-02-17

9150

Participants Needed

Research Sites

N/A

Total Duration

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 cirrhosischolangitis 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

Age: 18Years - 85Years

All Genders

Healthy Volunteers

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.

Research Team

Erik Schlicht, CCRP, B.A.

Jackie Bianchi

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Collection of Blood and Other Samples from Adults With Cholestatic Liver Diseases and Healthy Volunteers Including Primary Biliary CirrhosisCholangitis and Primary Sclerosing Cholangitis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria