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

NCT ID: NCT01150240

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Primary Immunodeficiency Disease

Study Design

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Observational Model Type

COHORT

Study Groups

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Primary Immunodeficiency Disease

Patients with primary Immunodeficiency disease (PID)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Primary Immunodeficiency Disease (PID)

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Helbling, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Bern, Inselspital

Christoph Hess, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Basel, University Hospital

Ayse H Ozsahin, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Geneva, University Hospital

Francois Spertini, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Lausanne, University Hospital

Hugo Ubieto, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Switzerland, St. Gallen

Reinhard A Seger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Zürich, University Children's Hospital

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

University Hospital Bern

Bern, , Switzerland

Site Status

University Children's Hospital Geneva

Geneva, , Switzerland

Site Status

University Hospital Lausanne

Lausanne, , Switzerland

Site Status

Children's Hospital of Eastern Switzerland and Cantonal Hospital

Sankt Gallen, , Switzerland

Site Status

University Children's Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PID_CH_Registry06

Identifier Type: -

Identifier Source: org_study_id

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