National Database on Primary Biliary Cholangitis
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage
University of Milano Bicocca
6,000 participants
Sep 19, 2019
OBSERVATIONAL
Conditions
Summary
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.
Eligibility
Inclusion Criteria4
- All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:
- elevated alkaline phosphatase and /or GGT;
- positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);
- characteristic histological features of florid bile ducts lesions and granulomatous lesion.
Exclusion Criteria1
- The patient has explicitly declared his/her unwillingness to participate to the study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.
Locations(55)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05151809