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

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ClinicalTrials.gov Identifier: NCT01150240
Recruitment Status : Unknown
Verified May 2016 by University of Zurich.
Recruitment status was:  Enrolling by invitation
First Posted : June 24, 2010
Last Update Posted : May 13, 2016
Sponsor:
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

Tracking Information
First Submitted Date June 23, 2010
First Posted Date June 24, 2010
Last Update Posted Date May 13, 2016
Study Start Date October 2006
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice
Condition Primary Immunodeficiency Disease
Intervention Not Provided
Study Groups/Cohorts Primary Immunodeficiency Disease
Patients with primary Immunodeficiency disease (PID)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†23,¬†2010)
800
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01150240
Other Study ID Numbers PID_CH_Registry06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators
  • 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
PRS Account University of Zurich
Verification Date May 2016