Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

• Conditions: Primary Immunodeficiency Disease

• Registration Number: NCT01150240
• Lead Sponsor: University of Zurich

Brief Summary

A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).

Detailed Description

The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients.

Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Primary Immunodeficiency Disease (PID)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland

University Children's Hospital Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Children's Hospital Geneva; 🇨🇭 Geneva, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland

Children's Hospital of Eastern Switzerland and Cantonal Hospital; 🇨🇭 St. Gallen, Switzerland