Clinical trial NCT03146910: Swiss Primary Biliary Cholangitis Cohort Study
Official title: Swiss Primary Biliary Cholangitis Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis, Biliary
Lead sponsor: Fondazione Epatocentro Ticino
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Primary biliary cholangitis according to recognized criteria (European Association for the Study of the Liver. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease course
timeFrame: 3 years
measure: Disease features
timeFrame: 3 years
measure: Response to treatment
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Transplantation-free survival rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
state: Ticino
city: Basel
country: Switzerland
facility: Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Lugano
country: Switzerland
facility: EOC Ospedale Regionale di Lugano - Italiano
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Epatocentro Ticino
name: Benedetta Terziroli Beretta-Piccoli, MD
role: PRINCIPAL_INVESTIGATOR
References: