Collecting bile samples from patients with Primary Sclerosing Cholangitis and controls
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04753996 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 diagnosed with PSC or healthy controls without chronic liver disease.
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.
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 performed: Other studies have shown promise in using organoids for understanding liver diseases, indicating that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
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.