Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
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, PSC 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 between the age of 18 and 85.
- 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.
- 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. Patients with PSC and Cholangiocarcinoma will be included.
- Controls
- Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- The study has 2 groups.
- Start date: 2021-03-08.
- Main results expected around 2035-01-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Primary Sclerosing Cholangitis (PSC)
- Control (non-PSC)
Main thing being measured
- Number of participants in study. (20 years)
In the researchers’ words
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
Words you might see
- Cholangiocarcinoma: cancer of the bile ducts.
- Cholestasis: reduced or blocked flow of bile.
- Biopsy / histology: a small tissue sample examined under a microscope.
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; PSC; Cholangiocarcinoma |
| Lead sponsor | Mayo Clinic |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 300 (estimated) |
| Start date | 2021-03-08 |
| Primary completion (est.) | 2035-01-01 |
| First posted | 2021-02-15 |
| Last updated | 2026-02-17 |
| Official title | Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients |
| ClinicalTrials.gov ID | NCT04753996 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: PSC * Patients diagnosed with PSC between the age of 18 and 85. * 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. * 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. Patients with PSC and Cholangiocarcinoma will be included. Controls • Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85. Exclusion Criteria: * Patients unable to provide inform consent. * Prisoners and institutionalized individuals. * PSC with orthotopic liver transplantation * History of Roux En Y procedure
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester | 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.