Interest of Flow Cytometry for the Diagnosis, the Follow... | NCT00805402

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

NCT00805402

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Jul 16, 2025Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Allergy

Interventions

flow cytometry

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2025

Last Update Posted Date

Jul 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 flow cytometry	Experimental	flow cytometry	Other: flow cytometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
flow cytometry	Other	flow cytometry	1 flow cytometry

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel COGNE, MD	CHU Limoges	Principal Investigator
Jean Sainte-Laudy, PhD	CHU Limoges	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Pathologie Respiratoire		Limoges		87000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27685197	Result	Sainte-Laudy J, Touraine F, Cluzan D, Belle Moudourou F. Follow-Up of Venom Immunotherapy on Flow Cytometry and Definition of a Protective Index. Int Arch Allergy Immunol. 2016;170(4):243-250. doi: 10.1159/000449162. Epub 2016 Sep 30.

ID	Term
D002469	Cell Separation
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures