Health TrialsbyHealthPanel

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

ConditionsPrimary Sclerosing CholangitisPSCCholangiocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMayo Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients unable to provide inform consent.

Prisoners and institutionalized individuals.

PSC with orthotopic liver transplantation

History of Roux En Y procedure

Trial population

Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Primary Sclerosing Cholangitis (PSC)
Group B: Control (non-PSC)

Trial outcomes

Primary outcomes

1

Number of participants in study.

Number of participants in study.

Time frame
20 years

Secondary outcomes

1

Number of samples (per type)

Number of samples collected (bile liquid, biliary cells)

Time frame
20 years
2

Number of clinical phenotypes and/or observations.

Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver ca development, organoids.)

Time frame
20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now