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

Status: Recruiting
Location: See location...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Erik Schlicht, CCRP, B.A.
schlicht.erik@mayo.edu
507-284-4312
Backup
Jackie Bianchi
bianchi.jackie@mayo.edu
507-266-0346
Time Frame
Start Date: 2017-01
Estimated Completion Date: 2050-01
Participants
Target number of participants: 9150
Treatments
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov