Biobank for Cholestatic Liver Diseases.

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03445585

Collaborator

(none)

9,150

Enrollment

Location

156

Duration (Months)

58.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Cholangiocarcinoma Liver Cancer

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

9150 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2030

Anticipated Study Completion Date :

Jan 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Primary Sclerosing Cholangitis Patients with a diagnosis of primary sclerosing cholangitis (PSC).
Primary Biliary Cirrhosis/Cholangitis Patients with a diagnosis of primary biliary cirrhosis (PBC).
Control group 1 Patients who do not have PBC or PSC but do have another form of chronic liver disease.
Control group 2 Patients without liver disease.

Outcome Measures

Primary Outcome Measures

Number of participants in the study. [20 years]
Number of participants in the study.

Secondary Outcome Measures

Number of samples collected (per type). [20 years]
Number of samples collected (blood, urine, stool, bile, bile duct cells)
Number of clinical phenotypes and/or endpoints observed (per category) [20 years]
Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver cancer development)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55901

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Konstantinos Lazaridis, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Konstantinos N. Lazaridis, M.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03445585

Other Study ID Numbers:

16-005892

First Posted:

Feb 26, 2018

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Cholangiocarcinoma

Liver Diseases

Cholangitis

Cholangitis, Sclerosing

Liver Cirrhosis, Biliary

Study Results

No Results Posted as of Feb 24, 2022