The Basophil Activation Test as a Diagnostic Tool in Pedi... | NCT03265262

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

NCT03265262

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Feb 5, 2026Actual

Enrollment

116Actual

Phase

Not Applicable

Conditions

FOOD ALLERGY

Interventions

The basophil activation test (BAT)

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

Feb 2026

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

Aug 4, 2017Actual

Primary Completion Date

Oct 4, 2018Actual

Completion Date

Oct 4, 2018Actual

First Submitted Date

Aug 25, 2017

First Submission Date that Met QC Criteria

Aug 25, 2017

First Posted Date

Aug 29, 2017Actual

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

Feb 4, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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

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

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children receiving OFC during a diagnost	Experimental	paediatric patients attending food allergy	Diagnostic Test: The basophil activation test (BAT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The basophil activation test (BAT)	Diagnostic Test	Single sample: 5 mL of venous blood	Children receiving OFC during a diagnost

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BAT positive and negative predictive values as compared with OFC	BAT versus OFC	2 years

Secondary Outcomes

Measure	Description	Time Frame
BAT quantitative results as compared with the minimal reacting dose for OFC	BAT versus OFC	2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urielle Desalbres	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille		13354	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32387696	Derived	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.

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases