Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy

Allergy Clinical Trial

— Cytoven  

Official title:

Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805402
• Other study ID #: I07021
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: September 3, 2010
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Intervention

Other:
• flow cytometry
flow cytometry

Locations

Country	Name	City	State
France	Service Pathologie Respiratoire	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% CD63 expression on basophil membrane by flow Cytometry		Inclusion , Week 1, Week 3, Week 10 and Week 21 visits	No
Secondary	Blood blocking factors level		Week 1, Week 3, Week 10 and Week 21 visits	No