Swiss Primary Biliary Cholangitis Cohort Study

• Conditions: Liver Cirrhosis, Biliary

• Registration Number: NCT03146910
• Lead Sponsor: Fondazione Epatocentro Ticino

Brief Summary

Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.

Detailed Description

Enrolment visit and one follow-up visit at least once a year are planned.

Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.

To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).
• Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included
• Patients/subjects aged at least 18 years and living in Switzerland are included

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease course	3 years	Observing disease course
Disease features	3 years	Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment	3 years	Observing response to treatment
Overall survival	3 years	Observing overall survival
Transplantation-free survival rate	3 years	Observing transplantation-free survival rate

Trial Locations

Locations (9)

Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel; 🇨🇭 Basel, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités; 🇨🇭 Geneve, Switzerland

Kantonsspital Baselland; 🇨🇭 Liestal, Switzerland

EOC Ospedale Regionale di Lugano - Italiano; 🇨🇭 Lugano, Switzerland

Kantonsspital St.Gallen; 🇨🇭 Sankt Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Universitätsspital Zürich; 🇨🇭 Zurich, Switzerland

Fondazione Epatocentro Ticino; 🇨🇭 Lugano, Ticino, Switzerland