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Recruiting NCT03445585

Biobank for Cholestatic Liver Diseases.

— Observational Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Cholangiocarcinoma Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Detailed 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).

Blood, saliva, stool, and urine samples will be collected periodically during patient visits, mail-home kit (collected locally), or via remote phlebotomy at a place directed by the subject. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures being performed at Mayo Clinic for clinical reasons. Anticipated research will focus on multi-omics assessments of biospecimens to better define how these diseases start and progress in order to develop novel tests for early detection of complication and better disease prognostication.

Primary outcome measures

  • Number of participants in the study. [Time frame: 20 years]
Secondary outcome measures (2)
  • Number of samples collected (per type). [Time frame: 20 years]
  • Number of clinical phenotypes and/or endpoints observed (per category) [Time frame: 20 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT03445585 · 16-005892

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗