Swiss Primary Biliary Cholangitis Cohort Study
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: PBC, Primary Biliary Cholangitis. Basic parameters: from 18 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
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Disease course [Time frame: 3 years]
- Disease features [Time frame: 3 years]
- Response to treatment [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
- Transplantation-free survival rate [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 13 centers
- Fondazione Epatocentro Ticino — Lugano
- Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel — Basel
- Inselspital — Bern
- Spital Bülach — Bülach
- Kantonsspital Graubünden — Chur
- Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département — Geneva
- CHUV: Centre hospitalier universitaire vaudois — Lausanne
- Kantonsspital Baselland — Liestal
- … and 5 more centers
Identifiers
NCT: NCT03146910 · SASL39 - Swiss PBC Cohort