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

Mayo Clinic

Status: Enrolling

Conditions: Primary Sclerosing Cholangitis; PSC; Cholangiocarcinoma

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04753996

20-012867

RC2DK118619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Primary Sclerosing Cholangitis (PSC)

Description:

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)

Description:

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).