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

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

This study has been completed.

First Received on December 2, 2008. Last Updated on September 3, 2010 History of Changes

Sponsor:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00805402

Purpose

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.

Condition	Intervention
Allergy	Other: flow cytometry

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy

Resource links provided by NLM:

MedlinePlus related topics: Allergy Cardiac Arrest

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

% CD63 expression on basophil membrane by flow Cytometry [ Time Frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood blocking factors level [ Time Frame: Week 1, Week 3, Week 10 and Week 21 visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	July 2008
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 flow cytometry flow cytometry	Other: flow cytometry flow cytometry

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805402

Locations

France
Service Pathologie Respiratoire
Limoges, France, 87000

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:	Michel COGNE, MD	CHU Limoges
Study Chair:	Jean Sainte-Laudy, PhD	CHU Limoges

More Information

No publications provided

Responsible Party:	CHU Limoges
ClinicalTrials.gov Identifier:	NCT00805402 History of Changes
Other Study ID Numbers:	I07021
Study First Received:	December 2, 2008
Last Updated:	September 3, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012