- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04753996
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
March 14, 2024 updated by: Konstantinos N. Lazaridis, M.D., Mayo Clinic
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.
Study Overview
Status
Recruiting
Conditions
Detailed 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
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erik Schlicht, CCRP
- Phone Number: (507) 284-4212
- Email: schlicht.erik@mayo.edu
Study Contact Backup
- Name: Jackie Bianchi
- Phone Number: (507) 266-0346
- Email: bianchi.jackie@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Jackie Bianchi
- Phone Number: 507-266-0346
- Email: bianchi.jackie@mayo.edu
-
Contact:
- Erik M Schlicht, B.A.,CCRP
- Phone Number: 507-284-4312
- Email: schlicht.erik@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants in study.
Time Frame: 20 years
|
Number of participants in study.
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of samples (per type)
Time Frame: 20 years
|
Number of samples collected (bile liquid, biliary cells)
|
20 years
|
Number of clinical phenotypes and/or observations.
Time Frame: 20 years
|
Number of clinical phenotypes and/or endpoints observed (i.e.
disease progression, liver ca development, organoids.)
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Konstantinos Lazaridis, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2021
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (Actual)
February 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-012867
- RC2DK118619 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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