<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/NCT04407104</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI100</org_study_id>
    <nct_id>NCT04407104</nct_id>
  </id_info>
  <brief_title>Allergy to Almond in Children</brief_title>
  <official_title>Allergy to Almond in Children: Diagnostic Values and Severity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Allergy to tree nuts are frequent in children but allergy to almond is one of the less&#xD;
      described tree nuts allergy. The main objective of our study is to determine diagnostic&#xD;
      values of skin prick-tests and specific IgE to almond in a population of children sensitized&#xD;
      to almond and challenged in our unit from november 2013 to march 2020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary objectives are&#xD;
&#xD;
        -  description of allergic reactions to almond (symptoms, severity)&#xD;
&#xD;
        -  modelisation of eliciting dose to almond in our population&#xD;
&#xD;
        -  evaluation of the association between atopic comorbidities and allergy to almond in&#xD;
           children sensitized to almond&#xD;
&#xD;
        -  evaluation of the association between allergy to almond and the importance of skin and&#xD;
           sIgE sensitization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 20, 2020</start_date>
  <completion_date type="Anticipated">September 7, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic values of skin prick-test and sIgE to almond</measure>
    <time_frame>BASELINE</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>allergic reactions during oral food challenge</measure>
    <time_frame>BASELINE</time_frame>
    <description>symptoms and severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eliciting doses to almond</measure>
    <time_frame>BASELINE</time_frame>
    <description>ED05, ED10 and ED50</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>atopic comorbidities</measure>
    <time_frame>BASELINE</time_frame>
    <description>respiratory allergies, other food allergies, asthma</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Food Allergy in Children</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>skin prick-test</intervention_name>
    <description>retrospective study on data already collected</description>
    <other_name>specific IgE</other_name>
    <other_name>oral food challenge</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children sensitized to almond and challenged in our unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  oral food challenge to almond performed in the pediatric allergy department of the&#xD;
             University Hospital of Nancy from november 2013 and march 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  doubtful or incomplete oral food challenge to almond&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>almond</keyword>
  <keyword>tree nuts</keyword>
  <keyword>atopy</keyword>
  <keyword>allergy</keyword>
  <keyword>children</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04407104
org study id: 2020PI100
nct id: NCT04407104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Allergy to tree nuts are frequent in children but allergy to almond is one of the less
      described tree nuts allergy. The main objective of our study is to determine diagnostic
      values of skin prick-tests and specific IgE to almond in a population of children sensitized
      to almond and challenged in our unit from november 2013 to march 2020.
Secondary objectives are

        -  description of allergic reactions to almond (symptoms, severity)

        -  modelisation of eliciting dose to almond in our population

        -  evaluation of the association between atopic comorbidities and allergy to almond in
           children sensitized to almond

        -  evaluation of the association between allergy to almond and the importance of skin and
           sIgE sensitization
observational model: Cohort
time perspective: Retrospective
measure: diagnostic values of skin prick-test and sIgE to almond
time frame: BASELINE
measure: allergic reactions during oral food challenge
time frame: BASELINE
description: symptoms and severity
measure: eliciting doses to almond
time frame: BASELINE
description: ED05, ED10 and ED50
measure: atopic comorbidities
time frame: BASELINE
description: respiratory allergies, other food allergies, asthma
intervention type: Diagnostic Test
intervention name: skin prick-test
description: retrospective study on data already collected
other name: specific IgE
other name: oral food challenge
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
sharing ipd: No