<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/NCT02966938</url>
  </required_header>
  <id_info>
    <org_study_id>OBS-048</org_study_id>
    <nct_id>NCT02966938</nct_id>
  </id_info>
  <brief_title>Visual Recognition of Allergens by Allergic Patients and/or Their Parents</brief_title>
  <acronym>REVIALL</acronym>
  <official_title>Visual Recognition of Allergens by Allergic Patients and/or Their Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Food allergies are constantly increasing. Peanut and nut allergies are a major cause of&#xD;
      allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had&#xD;
      an allergic reaction have another one in the following year with the same food, despite a&#xD;
      real improvement in industrial products labeling.&#xD;
&#xD;
      The investigators have observed in the allergy Unit that patients (and/or their family)&#xD;
      following an elimination diet, sometimes since several years, use very strict elimination&#xD;
      strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet,&#xD;
      a good identification of the allergen is the key to a successful elimination and the&#xD;
      non-identification a known risk factor.&#xD;
&#xD;
      Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were&#xD;
      allergic to. However, this is a US study, and geographical specificities have an impact on&#xD;
      food consumption and culture. Food allergology needs to take those two elements into account.&#xD;
      For example, in France, a single food can have two names. It is the case of peanut, which can&#xD;
      be called &quot;arachide&quot;, or more frequently &quot;cacahuète&quot;.&#xD;
&#xD;
      The goal of the study is to observe patient aptitudes to recognize peanut (and the&#xD;
      association between the two names) and other nuts available in France and define by the&#xD;
      European law, using a plate with various food samples in seed or in shell.&#xD;
&#xD;
      Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and&#xD;
      their families were surveyed with a standardized procedure at the beginning of their&#xD;
      therapeutic education and their capacity to recognize various nuts, to identify peanut&#xD;
      (&quot;cacahuète&quot; or &quot;arachide&quot;) and to associate the two words &quot;cacahuète&quot; and &quot;arachide&quot; was&#xD;
      assessed. It is a standard procedure in therapeutic education, and the responses have been&#xD;
      systematically entered in the medical record.&#xD;
&#xD;
      The main objective of this study is to describe peanut or nut allergic patient capacity&#xD;
      (adult, children and/or the family) to visually identify the foods there are allergic to.&#xD;
&#xD;
      The secondary objective of this study is to describe the capacity of patient that describe&#xD;
      themselves as allergic to &quot;arachide&quot; to associate this word to the word &quot;cacahuète&quot;.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patient that can visually identify the foods there are allergic to.</measure>
    <time_frame>At inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patients presenting themselves as allergic to &quot;arachide&quot; knowing it is a synonym of &quot;cacahuète&quot;</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">440</enrollment>
  <condition>Nut Allergy</condition>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Nut allergic patients</arm_group_label>
    <description>Allergic patient and their family with allergy to peanut or other tree nuts that are in elimination diet.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and their family with peanut or other nuts allergies followed in the allergy Unit&#xD;
        of Saint Vincent Hospital of Lille (France) from 2013 to 2015, that are following an&#xD;
        elimination diet and beginning a therapeutic education.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peanut or nut allergy&#xD;
&#xD;
          -  Following an elimination diet since at least 3 months&#xD;
&#xD;
          -  Results obtained at the beginning of a therapeutic education started from 2013 to 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients opposed to enter the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Sauvage, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</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>Peanut Hypersensitivity</mesh_term>
    <mesh_term>Nut 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/NCT02966938
org study id: OBS-048
nct id: NCT02966938
lead sponsor: 
has dmc: Yes
Food allergies are constantly increasing. Peanut and nut allergies are a major cause of
      allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had
      an allergic reaction have another one in the following year with the same food, despite a
      real improvement in industrial products labeling.

      The investigators have observed in the allergy Unit that patients (and/or their family)
      following an elimination diet, sometimes since several years, use very strict elimination
      strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet,
      a good identification of the allergen is the key to a successful elimination and the
      non-identification a known risk factor.

      Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were
      allergic to. However, this is a US study, and geographical specificities have an impact on
      food consumption and culture. Food allergology needs to take those two elements into account.
      For example, in France, a single food can have two names. It is the case of peanut, which can
      be called "arachide", or more frequently "cacahuète".

      The goal of the study is to observe patient aptitudes to recognize peanut (and the
      association between the two names) and other nuts available in France and define by the
      European law, using a plate with various food samples in seed or in shell.

      Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and
      their families were surveyed with a standardized procedure at the beginning of their
      therapeutic education and their capacity to recognize various nuts, to identify peanut
      ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was
      assessed. It is a standard procedure in therapeutic education, and the responses have been
      systematically entered in the medical record.

      The main objective of this study is to describe peanut or nut allergic patient capacity
      (adult, children and/or the family) to visually identify the foods there are allergic to.

      The secondary objective of this study is to describe the capacity of patient that describe
      themselves as allergic to "arachide" to associate this word to the word "cacahuète".
observational model: Case-Only
time perspective: Retrospective
measure: Number of patient that can visually identify the foods there are allergic to.
time frame: At inclusion
measure: number of patients presenting themselves as allergic to "arachide" knowing it is a synonym of "cacahuète"
time frame: at inclusion
arm group label: Nut allergic patients
description: Allergic patient and their family with allergy to peanut or other tree nuts that are in elimination diet.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Sauvage, MD
role: Principal Investigator
affiliation: GHICL
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
mesh term: Nut Hypersensitivity
sharing ipd: No