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
About this trial
This is an interventional diagnostic trial for FOOD ALLERGY
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
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
NCT ID
NCT03265262
First Posted
August 25, 2017
Last Updated
August 25, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
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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