Back to resultsInterest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy (Cytoven)
Primary Purpose
Allergy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
flow cytometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy
Eligibility Criteria
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
Sites / Locations
- Service Pathologie Respiratoire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 flow cytometry
Arm Description
flow cytometry
Outcomes
Primary Outcome Measures
% CD63 expression on basophil membrane by flow Cytometry
Secondary Outcome Measures
Blood blocking factors level
Full Information
NCT ID
NCT00805402
First Posted
December 2, 2008
Last Updated
September 3, 2010
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT00805402
Brief Title
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
Acronym
Cytoven
Official Title
Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 flow cytometry
Arm Type
Experimental
Arm Description
flow cytometry
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Description
flow cytometry
Primary Outcome Measure Information:
Title
% CD63 expression on basophil membrane by flow Cytometry
Time Frame
Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Secondary Outcome Measure Information:
Title
Blood blocking factors level
Time Frame
Week 1, Week 3, Week 10 and Week 21 visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel COGNE, MD
Organizational Affiliation
CHU Limoges
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Sainte-Laudy, PhD
Organizational Affiliation
CHU Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Service Pathologie Respiratoire
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
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