Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
2 other identifiers
observational
300
1 country
1
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 changes that occur in the liver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
February 17, 2026
February 1, 2026
13.8 years
February 9, 2021
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants in study.
Number of participants in study.
20 years
Secondary Outcomes (2)
Number of samples (per type)
20 years
Number of clinical phenotypes and/or observations.
20 years
Study Arms (2)
Primary Sclerosing Cholangitis (PSC)
Subjects diagnosed with Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal).
Control (non-PSC)
Subjects without a diagnosis of Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal).
Eligibility Criteria
Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.
You may qualify if:
- 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.
You may not qualify if:
- Patients unable to provide inform consent.
- Prisoners and institutionalized individuals.
- PSC with orthotopic liver transplantation
- History of Roux En Y procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Biospecimen
Collection of bile and biliary brushings collected at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konstantinos Lazaridis, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 15, 2021
Study Start
March 8, 2021
Primary Completion (Estimated)
January 1, 2035
Study Completion (Estimated)
January 1, 2035
Last Updated
February 17, 2026
Record last verified: 2026-02