Swiss Primary Sclerosing Cholangitis Cohort

Swiss Primary Sclerosing Cholangitis Cohort Study

This project will collect blood and other biological samples plus health information from people with primary sclerosing cholangitis in Switzerland to try to better understand the disease course and treatment responses.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Sex: All
• Sponsor: Fondazione Epatocentro Ticino (Academic / other)
• Locations: 21 sites (Lugano, Canton Ticino and 20 other locations)
• Trial ID: NCT03146936 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort that will enroll people with primary sclerosing cholangitis (PSC) across Swiss referral centers and collect standardized clinical data and biological samples for a biobank. Coded health-related personal data and biospecimens will be stored to enable longitudinal tracking of disease progression, treatment responses, and outcomes. The cohort provides a platform for multiple nested research projects and for collaboration with international PSC reference networks. No investigational treatments are given as part of this protocol; participation involves data collection and sample donation.

Who should consider this trial

Good fit: People of any age diagnosed with PSC (by EASL criteria or by a hepatology referral center) who live in Switzerland are eligible to join.

Not a fit: Individuals without PSC, those living outside Switzerland, or patients seeking direct access to experimental therapies are unlikely to receive direct clinical benefit from participating.

Why it matters

Potential benefit: If successful, the cohort and biobank could lead to clearer knowledge of PSC natural history, biomarkers of progression, and improved, more personalized care strategies for patients.

How similar studies have performed: Existing national and international PSC cohorts and biobanks have produced useful epidemiologic and biomarker findings, so this cohort follows an established and productive research model.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases) of any age. Patients not fulfilling such criteria but still diagnosed with PSC in a hepatology referral centre can be included
* patients living in Switzerland

Exclusion Criteria:

* N/A

Where this trial is running

Lugano, Canton Ticino and 20 other locations

• Fondazione Epatocentro Ticino — Lugano, Canton Ticino, Switzerland (Recruiting)
• Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum Universitätsspital Basel — Basel, Switzerland (Recruiting)
• Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung — Basel, Switzerland (Recruiting)
• Inselspital — Bern, Switzerland (Recruiting)
• Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung — Bern, Switzerland (Recruiting)
• Spital Bülach — Bülach, Switzerland (Recruiting)
• Kantonsspital Graubünden — Chur, Switzerland (Recruiting)
• Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent — Geneva, Switzerland (Recruiting)
• Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités — Geneva, Switzerland (Recruiting)
• CHUV: Centre hospitalier universitaire vaudois — Lausanne, Switzerland (Recruiting)
• CHUV Département femme-mère-enfant — Lausanne, Switzerland (Recruiting)
• Kantonsspital Baselland — Liestal, Switzerland (Recruiting)
• Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie — Lucerne, Switzerland (Recruiting)
• Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
• EOC Ospedale Regionale di Lugano - Italiano — Lugano, Switzerland (Recruiting)
• Ostschweizer Kinderspital — Sankt Gallen, Switzerland (Recruiting)
• Kantonsspital St.Gallen — Sankt Gallen, Switzerland (Recruiting)
• Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
• Pädiatrische Gastroenterologie Departement Kinder- und Jugendmedizin Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
• Universitäts-Kinderspital Zürich - Eleonorenstiftung — Zurich, Switzerland (Recruiting)
• Universitätsspital Zürich — Zurich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Andreas Cerny, Prof. Dr. med

Conditions Cholangitis, Sclerosing; PSC; Primary Sclerosing Cholangitis; Cohort