Status:
RECRUITING
Characterization of Biliary Cell-derived Organoids from Bile of PSC and Non-PSC Patients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Primary Sclerosing Cholangitis
PSC
Eligibility:
All Genders
18-85 years
Brief Summary
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 chang...
Detailed Description
The study will ask participants to provide bile and/or bile duct cytology brushings at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). The bile ...
Eligibility Criteria
Inclusion
- 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
- Patients unable to provide inform consent.
- Prisoners and institutionalized individuals.
- PSC with orthotopic liver transplantation
- History of Roux En Y procedure
Key Trial Info
Start Date :
March 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04753996
Start Date
March 8 2021
End Date
January 1 2035
Last Update
February 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905