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Biobank for Cholestatic Liver Diseases.

Mayo Clinic · NCT03445585

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
9150
US sites recruiting
1
Study start
January 2017
Record last updated
February 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Mayo Clinic

    Rochester, MN 55901

    Site contact: Erik M Schlicht, CCRP · 507-284-4312 · schlicht.erik@mayo.edu

Study contacts (from the official record)

  • Erik Schlicht, CCRP, B.A. · 507-284-4312 · schlicht.erik@mayo.edu
  • Jackie Bianchi · 507-266-0346 · bianchi.jackie@mayo.edu
Biobank for Cholestatic Liver Diseases. (NCT03445585) | Bored Studies