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- Reason if recruiting stopped or withdrawn: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
- Address:
- European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.Prof. Isabel Meyts (ESID President)Havengebouw, De Ruyterkade 7 (12th floor)1013 AA AmsterdamNetherlands
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://esid.org
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Immundefizienz (im CCI) Universitätsklinikum FreiburgDr. Gerhard KindleBreisacher Str. 11579106 FreiburgGermany
- Telephone:
- 0761 270 36961
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für Immundefizienz (CCI) Universitätsklinikum FreiburgDr. Gerhard KindleBreisacher Str. 11579106 FreiburgGermany
- Telephone:
- 0761 270 36961
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Immundefizienz (im CCI) Universitätsklinikum FreiburgDr. Gerhard KindleBreisacher Str. 11579106 FreiburgGermany
- Telephone:
- 0761 270 36961
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- European Society for Immunodeficiencies (ESID)c/o Kenes Education B.V.Havengebouw, De Ruyterkade 7 (12th floor)1013 AA Amsterdam, The NetherlandsNetherlands
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- 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
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