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Recruiting

NCT Number: NCT04753996

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

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants in study.

    Time frame: 20 years

    Number of participants in study.

Secondary outcomes

  1. Number of samples (per type)

    Time frame: 20 years

    Number of samples collected (bile liquid, biliary cells)

  2. Number of clinical phenotypes and/or observations.

    Time frame: 20 years

    Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver ca development, organoids.)

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Schlicht, CCRP

CONTACT

[email protected]

(507) 284-4212

Jackie Bianchi

CONTACT

[email protected]

(507) 266-0346

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2035
Study completion
2035
First posted
Feb 15, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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