Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04753996

Conditions

Primary Sclerosing Cholangitis

PSC

Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Primary Sclerosing Cholangitis

PSC

Cholangiocarcinoma

Study ID

NCT04753996

Start date

Mar 8, 2021

Status verified date

Feb, 2026

Completion date

Jan 1, 2035

Anticipated

Primary completion date

Jan 1, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Sclerosing Cholangitis (PSC)

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)

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).

Primary outcome measure

  • Number of participants in study. [ Time Frame: 20 years ]

Central Contacts and Locations

Central contacts

Erik Schlicht, CCRP

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

Jackie Bianchi

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Erik M Schlicht, B.A.,CCRP

507-284-4312schlicht.erik@mayo.edu

Jackie Bianchi

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

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-17.