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RecruitingNCT03445585

Biobank for Cholestatic Liver Diseases.

A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals

Sponsor

Mayo Clinic

Enrollment

9,150 participants

Start Date

Jan 1, 2017

Study Type

OBSERVATIONAL

Conditions

Liver CancerCholangiocarcinomaPrimary Sclerosing CholangitisPrimary Biliary Cirrhosis

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).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria14

  • 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.
  • 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.
  • PBC or PSC patients with known and overlapping other chronic liver diseases
  • Patients unable to provide informed consent
  • Prisoners and institutionalized individuals
  • PSC with orthotopic liver transplantation
  • History of Roux en Y

Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT03445585

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