<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265262</url>
  </required_header>
  <id_info>
    <org_study_id>2017-26</org_study_id>
    <nct_id>NCT03265262</nct_id>
  </id_info>
  <brief_title>The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy</brief_title>
  <official_title>Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The need for an oral food challenge (OFC) surrogate is growing in line with the&#xD;
      continuous increase in the prevalence and severity of paediatric food allergy. The basophil&#xD;
      activation test (BAT) has recently been reported as a promising tool for predicting the&#xD;
      outcome of OFC in children.&#xD;
&#xD;
      Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy&#xD;
      diagnosis and spare part of current OFC in paediatric patients attending allergy departments&#xD;
      in Marseille APHM University hospitals.&#xD;
&#xD;
      Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC&#xD;
      during a diagnostic or follow-up procedure.&#xD;
&#xD;
      Expected results: Good concordance of BAT and OFC results leading to potential OFC&#xD;
      replacement by BAT in at least 50% of the study population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BAT positive and negative predictive values as compared with OFC</measure>
    <time_frame>2 years</time_frame>
    <description>BAT versus OFC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BAT quantitative results as compared with the minimal reacting dose for OFC</measure>
    <time_frame>2 years</time_frame>
    <description>BAT versus OFC</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>FOOD ALLERGY</condition>
  <arm_group>
    <arm_group_label>Children receiving OFC during a diagnost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>paediatric patients attending food allergy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The basophil activation test (BAT)</intervention_name>
    <description>Single sample: 5 mL of venous blood</description>
    <arm_group_label>Children receiving OFC during a diagnost</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 0 - 18 years&#xD;
&#xD;
          -  Attending La Timone Paediatric Hospital for OFC&#xD;
&#xD;
          -  Social insurance&#xD;
&#xD;
          -  Parents and if possible child have received information and signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not receiving an OFC&#xD;
&#xD;
          -  Lack of social insurance&#xD;
&#xD;
          -  Inability to understand the study information&#xD;
&#xD;
          -  Unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle Desalbres</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ania CARSIN</last_name>
    <phone>04.91.68.67.65</phone>
    <email>ania.carsin@ap-hm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claire MORANDO</last_name>
    <email>claire.morando@ap-hm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ania CARSIN</last_name>
      <email>ania.carsin@ap-hm.fr</email>
    </contact>
    <contact_backup>
      <last_name>Claire MORANDO</last_name>
      <email>claire.morando@ap-hm.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265262
org study id: 2017-26
nct id: NCT03265262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: BAT positive and negative predictive values as compared with OFC
time frame: 2 years
description: BAT versus OFC
measure: BAT quantitative results as compared with the minimal reacting dose for OFC
time frame: 2 years
description: BAT versus OFC
arm group label: Children receiving OFC during a diagnost
arm group type: Experimental
description: paediatric patients attending food allergy
intervention type: Diagnostic Test
intervention name: The basophil activation test (BAT)
description: Single sample: 5 mL of venous blood
arm group label: Children receiving OFC during a diagnost
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Urielle Desalbres
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: Ania CARSIN
phone: 04.91.68.67.65
email: ania.carsin@ap-hm.fr
last name: Claire MORANDO
email: claire.morando@ap-hm.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity