Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

Recruiting

• Conditions: Primary Sclerosing Cholangitis; PSC; Cholangiocarcinoma

• Registration Number: NCT04753996
• Lead Sponsor: Mayo Clinic

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.

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 and brushings will be used to generate and perpetuate bile-derived organoids using an established matrigel-based protocol. These organoids will then be used in downstream experiments to better understand disease-specific alterations to biological pathways informative of disease pathogenesis

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Study Start: 2021-03-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

• Patients unable to provide inform consent.
• Prisoners and institutionalized individuals.
• PSC with orthotopic liver transplantation
• History of Roux En Y procedure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants in study.	20 years	Number of participants in study.

Secondary Outcome Measures

Name	Time	Method
Number of samples (per type)	20 years	Number of samples collected (bile liquid, biliary cells)
Number of clinical phenotypes and/or observations.	20 years	Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver ca development, organoids.)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States