Actively Recruiting
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
Led by Mayo Clinic · Updated on 2026-02-17
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Primary Sclerosing Cholangitis (PSC), a liver condition, by collecting bile, bile duct brushings, and medical information from people with PSC and from controls without the disease. The goal is to better understand the biological changes in the liver associated with PSC by creating bile-derived organoids, which are small, simplified versions of bile duct cells grown in the lab. Participants diagnosed with PSC or controls without chronic liver disease will provide samples of bile and/or bile duct brushings during medical procedures such as endoscopic retrograde cholangiopancreatography (ERCP) or gallbladder removal (cholecystectomy). These samples will be grown using a specific method to create organoids for research. Both PSC patients and control participants will follow the same sample collection process. During the study, researchers will analyze the number of participants, the number and types of samples collected, and various clinical observations over a planned period of 20 years. Participants will be asked to provide samples during their medical procedures, and their clinical information will be collected to support the research. The study is observational and involves monitoring and data collection to learn more about PSC and related conditions.
CONDITIONS
Brief Title
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Primary Sclerosing Cholangitis (PSC) between ages 18 and 85
- Diagnosis based on clinical and biochemical evidence of chronic cholestasis for at least six months, cholangiographic findings, and compatible liver biopsies if available
- Women of childbearing potential and pregnant women with PSC are eligible
- Patients with PSC and Cholangiocarcinoma are included
- Controls without history of PSC or other chronic liver disease, aged 18 to 85, of any gender
You will not qualify if you...
- Unable to provide informed consent
- Prisoners and institutionalized individuals
- Patients with PSC who have had orthotopic liver transplantation
- History of Roux En Y procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Occurs at the time of ERCP or cholecystectomy
Participants provide bile and/or bile duct cytology brushings during routine ERCP or cholecystectomy procedures.
1 visit (in-person)
Duration - Up to 20 years
Participants are observed for clinical phenotypes and outcomes related to their condition over time.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
E
Erik Schlicht, CCRP
J
Jackie Bianchi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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