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

September 3, 2010 updated by: University Hospital, Limoges

Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87000
        • Service Pathologie Respiratoire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 flow cytometry
flow cytometry
Other: flow cytometry
flow cytometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% CD63 expression on basophil membrane by flow Cytometry
Time Frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Inclusion , Week 1, Week 3, Week 10 and Week 21 visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood blocking factors level
Time Frame: Week 1, Week 3, Week 10 and Week 21 visits
Week 1, Week 3, Week 10 and Week 21 visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I07021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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