Biobank for cholestatic liver diseases
A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
This study is collecting samples and health information from people with cholestatic liver diseases to see if it can help us better understand these conditions and improve how we detect and predict them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03445585 on ClinicalTrials.gov |
What this trial studies
This study involves the creation of a biobank that collects specimens and clinical data from patients diagnosed with cholestatic liver diseases, specifically primary biliary cirrhosis and primary sclerosing cholangitis. Blood, saliva, stool, and urine samples will be gathered during patient visits or through mail-home kits, while bile and bile duct cells will be collected during necessary ERCP procedures. The aim is to utilize these biospecimens for multi-omics research to enhance understanding of disease onset and progression, ultimately leading to improved detection and prognostication methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with primary sclerosing cholangitis or primary biliary cirrhosis.
Not a fit: Patients with other liver diseases or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic tools and treatment strategies for patients with cholestatic liver diseases.
How similar studies have performed: Other studies utilizing biobanks for similar conditions have shown promise in advancing understanding and treatment, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Konstantinos Lazaridis, M.D. — Mayo Clinic
- Study coordinator: Erik Schlicht, CCRP, B.A.
- Email: schlicht.erik@mayo.edu
- Phone: 507-284-4312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.