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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:
ClinicalTrials.gov Identifier:
NCT00805402
First Posted: December 9, 2008
Last Update Posted: September 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Limoges
  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: None (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:


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 ]

Secondary Outcome Measures:
  • Blood blocking factors level [ Time Frame: Week 1, Week 3, Week 10 and Week 21 visits ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: CHU Limoges
ClinicalTrials.gov Identifier: NCT00805402     History of Changes
Other Study ID Numbers: I07021
First Submitted: December 2, 2008
First Posted: December 9, 2008
Last Update Posted: September 6, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases