Swiss Primary Biliary Cholangitis Cohort Study

April 19, 2022 updated by: Fondazione Epatocentro Ticino
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel
        • Contact:
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
      • Liestal, Switzerland, 4410
        • Recruiting
        • Kantonsspital Baselland
      • Lugano, Switzerland, 6900
        • Recruiting
        • EOC Ospedale Regionale di Lugano - Italiano
        • Contact:
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St.Gallen
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

Investigators

  • Principal Investigator: Benedetta Terziroli Beretta-Piccoli, MD, 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 15, 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

  • SASL39 - Swiss PBC 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.

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