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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Erik Schlicht, CCRP
schlicht.erik@mayo.edu
(507) 284-4212
Backup
Jackie Bianchi
bianchi.jackie@mayo.edu
(507) 266-0346
Time Frame
Start Date: 2021-03-08
Estimated Completion Date: 2035-01-01
Participants
Target number of participants: 300
Treatments
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).
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov