Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Sclerosing Cholangitis, PSC, Cholangiocarcinoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Number of participants in study. [Time frame: 20 years]
Secondary outcome measures (2)
- Number of samples (per type) [Time frame: 20 years]
- Number of clinical phenotypes and/or observations. [Time frame: 20 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04753996 · 20-012867 · RC2DK118619