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The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

Primary Purpose

FOOD ALLERGY

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The basophil activation test (BAT)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for FOOD ALLERGY

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 0 - 18 years
  • Attending La Timone Paediatric Hospital for OFC
  • Social insurance
  • Parents and if possible child have received information and signed the consent form

Exclusion Criteria:

  • Patients not receiving an OFC
  • Lack of social insurance
  • Inability to understand the study information
  • Unwilling to participate

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children receiving OFC during a diagnost

Arm Description

paediatric patients attending food allergy

Outcomes

Primary Outcome Measures

BAT positive and negative predictive values as compared with OFC
BAT versus OFC

Secondary Outcome Measures

BAT quantitative results as compared with the minimal reacting dose for OFC
BAT versus OFC

Full Information

First Posted
August 25, 2017
Last Updated
August 25, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03265262
Brief Title
The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy
Official Title
Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children. Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals. Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure. Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FOOD ALLERGY

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children receiving OFC during a diagnost
Arm Type
Experimental
Arm Description
paediatric patients attending food allergy
Intervention Type
Diagnostic Test
Intervention Name(s)
The basophil activation test (BAT)
Intervention Description
Single sample: 5 mL of venous blood
Primary Outcome Measure Information:
Title
BAT positive and negative predictive values as compared with OFC
Description
BAT versus OFC
Time Frame
2 years
Secondary Outcome Measure Information:
Title
BAT quantitative results as compared with the minimal reacting dose for OFC
Description
BAT versus OFC
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 0 - 18 years Attending La Timone Paediatric Hospital for OFC Social insurance Parents and if possible child have received information and signed the consent form Exclusion Criteria: Patients not receiving an OFC Lack of social insurance Inability to understand the study information Unwilling to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ania CARSIN
Phone
04.91.68.67.65
Email
ania.carsin@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire MORANDO
Email
claire.morando@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ania CARSIN
Email
ania.carsin@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Claire MORANDO
Email
claire.morando@ap-hm.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32387696
Citation
Arif-Lusson R, Agabriel C, Carsin A, Cabon I, Senechal H, Poncet P, Vitte J, Busnel JM. Streamlining basophil activation testing to enable assay miniaturization and automation of sample preparation. J Immunol Methods. 2020 Jun-Jul;481-482:112793. doi: 10.1016/j.jim.2020.112793. Epub 2020 May 6.
Results Reference
derived

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The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

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