Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
Cytoven
1 other identifier
interventional
75
1 country
1
Brief Summary
The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy. 75 patients having a story of reaction to hymenoptera venom will be selected for this trial. Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 16, 2025
September 1, 2010
2 years
December 2, 2008
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
% CD63 expression on basophil membrane by flow Cytometry
Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Secondary Outcomes (1)
Blood blocking factors level
Week 1, Week 3, Week 10 and Week 21 visits
Study Arms (1)
1 flow cytometry
EXPERIMENTALflow cytometry
Interventions
Eligibility Criteria
You may qualify if:
- Adult patient (18 - 70 years)
- Patient being informed and accepting to participate in the study with signature of informed consent
- Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.
- Patients treated by SIT for at least 5 years
- Patients benefiting from a national insurance health
You may not qualify if:
- Children
- Pregnant woman or who breast-feed
- Patient under antihistaminic or corticoid for less than 8 days before the blood drawing
- Protected Patient
- Patient not having given his agreement after it was informed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service Pathologie Respiratoire
Limoges, 87000, France
Related Publications (1)
Sainte-Laudy J, Touraine F, Cluzan D, Belle Moudourou F. Follow-Up of Venom Immunotherapy on Flow Cytometry and Definition of a Protective Index. Int Arch Allergy Immunol. 2016;170(4):243-250. doi: 10.1159/000449162. Epub 2016 Sep 30.
PMID: 27685197BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel COGNE, MD
CHU Limoges
- STUDY CHAIR
Jean Sainte-Laudy, PhD
CHU Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 9, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 16, 2025
Record last verified: 2010-09