Recruiting

Cholestatic Liver Diseases

Sponsor:

Mayo Clinic

Code:

NCT03445585

Conditions

Primary Sclerosing Cholangitis

Primary Biliary Cirrhosis

Cholangiocarcinoma

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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).

Conditions

Primary Sclerosing Cholangitis

Primary Biliary Cirrhosis

Cholangiocarcinoma

Liver Cancer

Study ID

NCT03445585

Start date

Jan, 2017

Status verified date

Feb, 2026

Completion date

Jan, 2050

Anticipated

Primary completion date

Jan, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

9150 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Sclerosing Cholangitis

Patients with a diagnosis of primary sclerosing cholangitis (PSC).

Primary Biliary Cirrhosis/Cholangitis

Patients with a diagnosis of primary biliary cirrhosis (PBC).

Control group 1

Patients who do not have PBC or PSC but do have another form of chronic liver disease.

Control group 2

Patients without liver disease.

Primary outcome measure

  • Number of participants in the study. [ Time Frame: 20 years ]

Central Contacts and Locations

Central contacts

Erik Schlicht, CCRP, B.A.

507-284-4312schlicht.erik@mayo.edu

Jackie Bianchi

507-266-0346bianchi.jackie@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Erik M Schlicht, CCRP

507-284-4312schlicht.erik@mayo.edu

Principal Investigator:

Konstantinos N Lazaridis, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-17.