Biobank for Cholestatic Liver Diseases.

Description

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 Overview

Study Details

Study overview

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).

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

Biobank for Cholestatic Liver Diseases.

Condition
Primary Sclerosing Cholangitis
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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 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.
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mayo Clinic,

Konstantinos Lazaridis, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2050-01