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

May 12, 2016 updated by: University of Zurich
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).

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel
      • Bern, Switzerland
        • University Hospital Bern
      • Geneva, Switzerland
        • University Children's Hospital Geneva
      • Lausanne, Switzerland
        • University Hospital Lausanne
      • St. Gallen, Switzerland
        • Children's Hospital of Eastern Switzerland and Cantonal Hospital
      • Zurich, Switzerland
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice

Description

Inclusion Criteria:

  • Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary Immunodeficiency Disease
Patients with primary Immunodeficiency disease (PID)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Geneva
University of Lausanne
University of Bern
University of Basel
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID_CH_Registry06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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