NCT03445585 Biobank for Cholestatic Liver Diseases.
| NCT ID | NCT03445585 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 9,150 participants |
| Start Date | 2017-01 |
| Primary Completion | 2050-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 9,150 participants in total. It began in 2017-01 with a primary completion date of 2050-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Konstantinos Lazaridis, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03445585 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03445585 currently recruiting?
Yes, NCT03445585 is actively recruiting participants. Contact the research team at schlicht.erik@mayo.edu for enrollment information.
Where is the NCT03445585 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03445585 clinical trial?
NCT03445585 is sponsored by Mayo Clinic. The principal investigator is Konstantinos Lazaridis, M.D. at Mayo Clinic. The trial plans to enroll 9,150 participants.