- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03265262
The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy
Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ania CARSIN
- Phone Number: 04.91.68.67.65
- Email: ania.carsin@ap-hm.fr
Study Contact Backup
- Name: Claire MORANDO
- Email: claire.morando@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Claire MORANDO
- Email: claire.morando@ap-hm.fr
-
Contact:
- Ania CARSIN
- Email: ania.carsin@ap-hm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children receiving OFC during a diagnost
paediatric patients attending food allergy
|
Single sample: 5 mL of venous blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BAT positive and negative predictive values as compared with OFC
Time Frame: 2 years
|
BAT versus OFC
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BAT quantitative results as compared with the minimal reacting dose for OFC
Time Frame: 2 years
|
BAT versus OFC
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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