Primary Sclerosing CholangitisRare disease
What this study is
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).
Study details
- Official title
- A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
- Sponsor
- Mayo Clinic
- Conditions
- Primary Sclerosing Cholangitis · Primary Biliary Cirrhosis · Cholangiocarcinoma · Liver Cancer
- Enrolling
- 9,150 people
- Starts
- 2017-01
- Est. completion
- 2050-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- PBC or PSC patients with known and overlapping other chronic liver diseases
- Patients unable to provide informed consent
- Prisoners and institutionalized individuals
- PSC with orthotopic liver transplantation
- History of Roux en Y
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
- Erik M Schlicht, CCRP · Contact507-284-4312schlicht.erik@mayo.edu
- Konstantinos N Lazaridis, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 16-005892
Principal investigator
Konstantinos Lazaridis, M.D.
Mayo Clinic
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.