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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150240
First Posted: June 24, 2010
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Basel
University of Bern
University Hospital, Geneva
University of Lausanne
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
University of Zurich
  Purpose
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).

Condition
Primary Immunodeficiency Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Estimated Enrollment: 800
Study Start Date: October 2006
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Immunodeficiency Disease
Patients with primary Immunodeficiency disease (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice
Criteria

Inclusion Criteria:

  • Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150240


Locations
Switzerland
University Hospital Basel
Basel, Switzerland
University Hospital Bern
Bern, Switzerland
University Children's Hospital Geneva
Geneva, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
Children's Hospital of Eastern Switzerland and Cantonal Hospital
St. Gallen, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
University of Basel
University of Bern
University Hospital, Geneva
University of Lausanne
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Arthur Helbling, Prof. University Bern, Inselspital
Principal Investigator: Christoph Hess, Prof. University Basel, University Hospital
Principal Investigator: Ayse H Ozsahin, Prof. University Geneva, University Hospital
Principal Investigator: Francois Spertini, Prof. University Lausanne, University Hospital
Principal Investigator: Hugo Ubieto, MD Children's Hospital of Eastern Switzerland, St. Gallen
Principal Investigator: Reinhard A Seger, Prof. University Zürich, University Children's Hospital
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01150240     History of Changes
Other Study ID Numbers: PID_CH_Registry06
First Submitted: June 23, 2010
First Posted: June 24, 2010
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by University of Zurich:
Primary Immunodeficiency Disease

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases