PSCRecruiting
Biobank for Cholestatic Liver Diseases.
Observational · No treatment assigned · 1 site · Mayo Clinic
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis and Cholangiocarcinoma. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 85
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 8 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 9150 participants are expected to take part.
- The study has 4 groups.
- Start date: 2017-01.
- Main results expected around 2050-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Primary Sclerosing Cholangitis
- Primary Biliary Cirrhosis/Cholangitis
- Control group 1
- Control group 2
Main thing being measured
- Number of participants in the study. (20 years)
In the researchers’ words
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).
Words you might see
- ERCP: a procedure using a scope and dye to look at (and sometimes treat) the bile ducts.
- Cirrhosis: advanced scarring of the liver.
- Cholestasis: reduced or blocked flow of bile.
- Biopsy / histology: a small tissue sample examined under a microscope.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Primary Sclerosing Cholangitis; Primary Biliary Cirrhosis; Cholangiocarcinoma; Liver Cancer |
| Lead sponsor | Mayo Clinic |
| Enrollment | 9150 (estimated) |
| Start date | 2017-01 |
| Primary completion (est.) | 2050-01 |
| First posted | 2018-02-26 |
| Last updated | 2026-02-17 |
| Official title | A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals |
| ClinicalTrials.gov ID | NCT03445585 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.