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

Organizational Data

DRKS-ID:
DRKS00007776
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2015-02-05
Last update in DRKS:
2023-01-13
Registration type:
Retrospective

Acronym/abbreviation of the study

ESID Registry

URL of the study

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

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.

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.

Health condition or problem studied

ICD10:
D84 - Other immunodeficiencies
ICD10:
D80 - Immunodeficiency with predominantly antibody defects
ICD10:
D81 - Combined immunodeficiencies
ICD10:
D82 - Immunodeficiency associated with other major defects
ICD10:
D83 - Common variable immunodeficiency
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
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

Endpoints

Primary outcome:
Determine the epidemiology of primary immunodeficiencies (PID)
Secondary outcome:
Correlation of clinical features, life expectancy, complications, medication effects

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Egypt
  • France
  • Germany
  • Hungary
  • Iran
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Freiburg
  • University medical center Hannover

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-12-11
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
30000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Diagnosis of a primary immunodeficiency

Exclusion Criteria

Diagnosis of a secondary immunodeficiency

Addresses

Primary Sponsor

European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.
Prof. Isabel Meyts (ESID President)
Havengebouw, De Ruyterkade 7 (12th floor)
1013 AA Amsterdam
Netherlands
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://esid.org
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Immundefizienz (im CCI) Universitätsklinikum Freiburg
Dr. Gerhard Kindle
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
0761 270 36961
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Immundefizienz (CCI) Universitätsklinikum Freiburg
Dr. Gerhard Kindle
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
0761 270 36961
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Institut für Immundefizienz (im CCI) Universitätsklinikum Freiburg
Dr. Gerhard Kindle
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
0761 270 36961
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.
Havengebouw, De Ruyterkade 7 (12th floor)
1013 AA Amsterdam, The Netherlands
Netherlands
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-10-08
Ethics committee number:
493/14
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-12-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
See data access and publication rules on www.esid.org

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry