Biobank for Cholestatic Liver Diseases.

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03445585
• Other study ID #: 16-005892
• Status: Recruiting
• Start date: January 2017
• Est. completion date: January 2050

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Erik Schlicht, CCRP, B.A.
• Phone: 507-284-4312
• Email: schlicht.erik[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9150
• Est. completion date: January 2050
• Est. primary completion date: January 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangitis
• Cholangitis, Sclerosing
• Liver Cancer
• Liver Cirrhosis, Biliary
• Liver Diseases
• Primary Biliary Cirrhosis
• Primary Sclerosing Cholangitis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in the study.	Number of participants in the study.	20 years
Secondary	Number of samples collected (per type).	Number of samples collected (blood, urine, stool, bile, bile duct cells)	20 years
Secondary	Number of clinical phenotypes and/or endpoints observed (per category)	Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver cancer development)	20 years