Biobank for Cholestatic Liver Diseases.

Mayo Clinic

Status: Enrolling

Conditions: Primary Sclerosing Cholangitis; Cholangiocarcinoma; Liver Cancer; Primary Biliary Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT03445585

16-005892

Details and patient eligibility

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).

Full 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 or via a mail-home kit. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. 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.

Enrollment: 9,150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

9,150 participants in 4 patient groups

Primary Sclerosing Cholangitis

Description:

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

Primary Biliary Cirrhosis/Cholangitis

Description:

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

Control group 1

Description:

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

Control group 2

Description:

Patients without liver disease.