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Search / Trial NCT04753996

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

Launched by MAYO CLINIC · Feb 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at bile samples and other medical information from patients with Primary Sclerosing Cholangitis (PSC) and healthy individuals. The goal is to better understand the changes that happen in the liver of people with PSC, a condition that affects the bile ducts, and to compare these findings with those from people who do not have PSC. By studying this, researchers hope to gain insights that could improve diagnosis and treatment for PSC and related conditions, like cholangiocarcinoma, a type of bile duct cancer.

To be eligible for this study, participants need to be between 18 and 85 years old. People with a confirmed diagnosis of PSC are welcome to join, including those who are pregnant, as the study poses no risk to unborn children. Healthy individuals who have no history of PSC or other chronic liver diseases can also participate. If you decide to join, you will provide bile samples and some medical information, and you’ll be contributing to important research that could help others in the future. It's important to note that some individuals, like those who cannot give consent or have had certain types of surgery, are not eligible to participate.

Gender

ALL

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Konstantinos Lazaridis, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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