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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.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00805402
First received: December 2, 2008
Last updated: September 3, 2010
Last verified: September 2010
History of Changes
  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:

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013