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Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients | Clinical Trials | Clareo Health

RECRUITING

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

NCT04753996•Mayo Clinic

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

March 8, 2021

Primary Completion Date

January 1, 2035

Completion Date

January 1, 2035

Last Updated

February 17, 2026

Enrollment

300

ESTIMATED participants

Conditions

Primary Sclerosing CholangitisPSCCholangiocarcinoma

Contacts

Erik Schlicht, CCRP

CONTACT

(507) 284-4212 schlicht.erik@mayo.edu

Jackie Bianchi

CONTACT

(507) 266-0346 bianchi.jackie@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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