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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753996
• Other study ID #: 20-012867
• Secondary ID: RC2DK118619
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Erik Schlicht, CCRP
• Phone: (507) 284-4212
• Email: schlicht.erik[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis
• PSC

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in study.	Number of participants in study.	20 years
Secondary	Number of samples (per type)	Number of samples collected (bile liquid, biliary cells)	20 years
Secondary	Number of clinical phenotypes and/or observations.	Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver ca development, organoids.)	20 years