NCT00805402CompletedNot Applicable
Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy
University Hospital, Limoges2 sites in 1 country75 target enrollmentStarted: July 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- % CD63 expression on basophil membrane by flow Cytometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
% CD63 expression on basophil membrane by flow Cytometry
Time Frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Secondary Outcomes
- Blood blocking factors level(Week 1, Week 3, Week 10 and Week 21 visits)
Investigators
Study Sites (2)
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