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Observational Study of Biliary Cell Organoids in PSC

This study aims to understand changes in the liver by collecting bile, bile duct brushings, and medical information from people with Primary Sclerosing Cholangitis (PSC) and others without the condition. Researchers will use these samples to grow "organoids" (miniature, simplified versions of organs grown in a lab) from bile cells. These organoids will help scientists learn more about how PSC develops. You may be able to join if you are 18 to 85 years old and have been diagnosed with PSC based on standard medical criteria. The study plans to enroll 300 participants, and its main goal is to track the number of participants over 20 years. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 300 participants. It is not testing a specific treatment, but rather collecting samples and information.
What's involved
You would provide bile and/or bile duct brushings during an ERCP (a procedure to examine bile ducts) or gallbladder removal surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the number of participants in the study over 20 years, suggesting a long-term follow-up period.

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NCT04753996

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

Recruiting
Not specifiedAges 18–85Observational
Mayo Clinic
~300 participants
Updated 2026-02-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants in study.
Measured over 20 years

Conditions

Primary Sclerosing Cholangitis
PSC
Cholangiocarcinoma

Explore related trials

CholangiocarcinomaPrimary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Konstantinos Lazaridis, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Erik Schlicht, CCRP
[email protected]
(507) 284-4212
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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Number of participants in study.20 years

    Number of participants in study.