NCT04753996 Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
| NCT ID | NCT04753996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2035-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-03-08 with a primary completion date of 2035-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Konstantinos Lazaridis, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04753996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04753996 currently recruiting?
Yes, NCT04753996 is actively recruiting participants. Contact the research team at schlicht.erik@mayo.edu for enrollment information.
Where is the NCT04753996 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04753996 clinical trial?
NCT04753996 is sponsored by Mayo Clinic. The principal investigator is Konstantinos Lazaridis, MD at Mayo Clinic. The trial plans to enroll 300 participants.