Mayo clinic launches massive biobank to unlock secrets of rare liver diseases
NCT ID NCT03445585
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is creating a large collection of blood, urine, stool, bile, and bile duct cells from up to 9,150 people with cholestatic liver diseases like primary biliary cholangitis and primary sclerosing cholangitis, as well as from healthy volunteers. The samples and medical data will be used by researchers to better understand these conditions. No new treatments are being tested; the goal is to gather resources for future discoveries.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 9,150 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jan 2017
- Expected to finish
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Jan 2050
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55901, United States
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