Collecting bile samples from patients with Primary Sclerosing Cholangitis and controls
Official title: Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
Run by Mayo Clinic · NCT04753996 · Data updated 2026-11-12
This study is collecting bile samples from people with Primary Sclerosing Cholangitis and healthy individuals to see how the disease affects the body and find new ways to treat it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | March 8, 2021 |
| Main results expected | January 1, 2035 |
| Study ends | January 1, 2035 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT04753996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-85 diagnosed with PSC or healthy controls without chronic liver disease.
✕Probably not a fit
Patients unable to provide informed consent or those with a history of liver transplantation or specific surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to gather bile, bile duct brushings, and medical information from individuals diagnosed with Primary Sclerosing Cholangitis (PSC) and healthy controls. Participants will provide samples during procedures like endoscopic retrograde cholangiopancreatography (ERCP) or gallbladder removal. The collected samples will be used to create bile-derived organoids, which will help researchers investigate disease-specific changes in biological pathways related to PSC and cholangiocarcinoma. This approach seeks to enhance understanding of the disease's pathogenesis and potential therapeutic targets.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with PSC and cholangiocarcinoma.
How similar studies have gone: Other studies have shown promise in using organoids for understanding liver diseases, indicating that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Konstantinos Lazaridis, MD — Mayo Clinic
- Study coordinator: Erik Schlicht, CCRP
- Email: schlicht.erik@mayo.edu
- Phone: (507) 284-4212
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.