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

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ClinicalTrials.gov Identifier: NCT00805402
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Allergy Other: flow cytometry Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 flow cytometry
flow cytometry
Other: flow cytometry
flow cytometry




Primary Outcome Measures :
  1. % CD63 expression on basophil membrane by flow Cytometry [ Time Frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases