Clinical trial NCT01150240: Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland
Official title: Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Immunodeficiency Disease
Keywords: Primary Immunodeficiency Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Basel
name: University of Bern
name: University Hospital, Geneva
name: University of Lausanne
name: Cantonal Hospital of St. Gallen
First posted: 2010-06-24
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice

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.

Eligibility criteria: Inclusion Criteria:

* Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Geneva
country: Switzerland
facility: University Children's Hospital Geneva
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: St. Gallen
country: Switzerland
facility: Children's Hospital of Eastern Switzerland and Cantonal Hospital
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Bern, Inselspital
name: Arthur Helbling, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Basel, University Hospital
name: Christoph Hess, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Geneva, University Hospital
name: Ayse H Ozsahin, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Lausanne, University Hospital
name: Francois Spertini, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Eastern Switzerland, St. Gallen
name: Hugo Ubieto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Zürich, University Children's Hospital
name: Reinhard A Seger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: