Swiss Primary Sclerosing Cholangitis Cohort Study

April 19, 2022 updated by: Fondazione Epatocentro Ticino

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

Coded data are used.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung
      • Basel, Switzerland, 4031
        • Recruiting
        • Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum Universitätsspital Basel
        • Contact:
      • Bern, Switzerland, 3010
      • Bern, Switzerland, 3010
        • Recruiting
        • Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden, Departement für Kinder- und Jugendmedizin
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV Département femme-mère-enfant
        • Contact:
      • Liestal, Switzerland, 4410
        • Recruiting
        • Kantonsspital Baselland
      • Lucerne, Switzerland, 6000
        • Recruiting
        • Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie
      • Lugano, Switzerland, 6900
        • Recruiting
        • EOC Ospedale Regionale di Lugano - Italiano
        • Contact:
      • Sankt Gallen, Switzerland, 9006
        • Recruiting
        • Ostschweizer Kinderspital
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St.Gallen
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur
        • Contact:
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Pädiatrische Gastroenterologie Departement Kinder- und Jugendmedizin Kantonsspital Winterthur
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitatsspital Zurich
      • Zurich, Switzerland, 8032
        • Recruiting
        • Universitäts-Kinderspital Zürich - Eleonorenstiftung
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Recruiting
        • Fondazione Epatocentro Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PSC patients living in Switzerland of any age 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). Only patients living in Switzerland are enrolled. Enrollment of minors is possible upon consent of legal guardian

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Epatocentro Ticino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SASL40 - Swiss PSC Cohort

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangitis, Sclerosing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe