Swiss Primary Biliary Cholangitis Cohort Study

Liver Cirrhosis, Biliary Clinical Trial

Official title:

Swiss Primary Biliary Cholangitis Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146910
• Other study ID #: SASL39 - Swiss PBC Cohort
• Status: Recruiting
• Start date: February 15, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Fondazione Epatocentro Ticino
• Contact: Benedetta Terziroli Beretta-Piccoli, MD
• Phone: +41919608503
• Email: benedetta.terziroli[@]hin.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary

Locations

Country	Name	City	State
Switzerland	Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités	Geneve
Switzerland	Kantonsspital Baselland	Liestal
Switzerland	EOC Ospedale Regionale di Lugano - Italiano	Lugano
Switzerland	Fondazione Epatocentro Ticino	Lugano	Ticino
Switzerland	Kantonsspital St.Gallen	Sankt Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Universitätsspital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Epatocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

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