Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007776

Trial Description

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Title

Clinical and Laboratory Online Patient- and Research Registry for Primary Immunodeficiencies
of the European Society for Immunodeficiencies (ESID)

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Trial Acronym

ESID Registry

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URL of the Trial

https://esid.org/Working-Parties/Registry-Working-Party/ESID-Registry

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Brief Summary in Lay Language

The Registry provides long term documentation of patients with primary (inborn) immunodeficiencies. These include e.g. common variable immunodeficiency (CVID) and severe combined immunodeficiency (SCID). The registry data makes it possible to determine the frequency of single diseases, as well as possible factors that may be related to the benefit of specific therapies.

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Brief Summary in Scientific Language

The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. For this purpose, data is collected long-term, providing follow-up information for longitudinal analyses.

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Organizational Data

  •   DRKS00007776
  •   2015/02/05
  •   [---]*
  •   yes
  •   Approved
  •   493/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D84 -  Other immunodeficiencies
  •   D80 -  Immunodeficiency with predominantly antibody defects
  •   D81 -  Combined immunodeficiencies
  •   D82 -  Immunodeficiency associated with other major defects
  •   D83 -  Common variable immunodeficiency
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Interventions/Observational Groups

  •   Baseline documentation: Age, sex, familial cases, first symptoms, diagnosis, haemtopoietic stem cell transplantation (HSCT), immunoglobulin replacement (Ig replacement), lab values, clinical features; Yearly follow-up: living status, therapy status (HSCT, Ig replacement), changes to diagnosis, lab values, clinical features
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determine the epidemiology of primary immunodeficiencies (PID)

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Secondary Outcome

Correlation of clinical features, life expectancy, complications, medication effects

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Countries of Recruitment

  •   Germany
  •   France
  •   United Kingdom
  •   Switzerland
  •   Austria
  •   Poland
  •   Czech Republic
  •   Slovakia
  •   Slovenia
  •   Hungary
  •   Spain
  •   Italy
  •   Egypt
  •   Israel
  •   Iran, Islamic Republic of
  •   Croatia
  •   Netherlands
  •   Belgium
  •   Ireland
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2014/12/11
  •   30000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Diagnosis of a primary immunodeficiency

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Exclusion Criteria

Diagnosis of a secondary immunodeficiency

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Addresses

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    • European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.
    • Ms.  Prof.  Isabel  Meyts (ESID President) 
    • Havengebouw, De Ruyterkade 7 (12th floor)
    • 1013   AA Amsterdam
    • Netherlands
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    • Institut für Immundefizienz (im CCI) Universitätsklinikum Freiburg
    • Mr.  Dr.  Gerhard  Kindle 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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    • Institut für Immundefizienz (CCI) Universitätsklinikum Freiburg
    • Mr.  Dr.  Gerhard  Kindle 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.
    • Ms.  Prof.  Isabel  Meyts (ESID President) 
    • Havengebouw, De Ruyterkade 7 (12th floor)
    • 1013   AA Amsterdam, The Netherlands
    • Netherlands
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.