Biobank for Cholestatic Liver Diseases.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMayo Clinic
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients with PBC, PSC, controls without liver disease, and with other chronic liver disease without history of PBC or PSC seen or followed at Mayo Clinic will be invited to participate in this study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
9,150 Participants
are grouped into 4 trial groupsGroup A: Primary Sclerosing Cholangitis
Group B: Primary Biliary Cirrhosis/Cholangitis
Group C: Control group 1
Group D: Control group 2
Trial outcomes
Primary outcomes
1
Number of participants in the study.
Number of participants in the study.
Time frame
20 yearsSecondary outcomes
1
Number of samples collected (per type).
Number of samples collected (blood, urine, stool, bile, bile duct cells)
Time frame
20 years2
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)
Time frame
20 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov