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Recruiting NCT03146936

Swiss Primary Sclerosing Cholangitis Cohort Study

Observational Cholangitis, Sclerosing PSC Primary Sclerosing Cholangitis (PSC)

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: Cholangitis, Sclerosing, PSC, Primary Sclerosing Cholangitis (PSC). Basic parameters: No limits · 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 →

Overview

Research project in which biological material is sampled and health-related personal data is further used and collected. Coded data are used.

Detailed description

The investigators wish to collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a 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 PSC. In addition, the cohort will allow collaborations with reference networks on PSC 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

  • 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

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 · 21 centers
  • Fondazione Epatocentro Ticino — Lugano
  • Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum Universitätsspital — Basel
  • Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung — Basel
  • Inselspital — Bern
  • Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie u — Bern
  • Spital Bülach — Bülach
  • Kantonsspital Graubünden — Chur
  • Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Départe — Geneva
  • … and 13 more centers

Identifiers

NCT: NCT03146936 · SASL40 - Swiss PSC Cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗