xml: <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/NCT06038019</url>
    </required_header>
    <id_info>
      <org_study_id>NIF-20500</org_study_id>
      <nct_id>NCT06038019</nct_id>
    </id_info>
    <brief_title>Thresholds In Food Allergy evaluaTion And predictioN</brief_title>
    <acronym>TITAN</acronym>
    <official_title>Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamilton Health Sciences Corporation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AAAAI Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hamilton Health Sciences Corporation</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry.&#xD;
        The aim is to quantify food allergy thresholds in Canada and their clinical predictors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2051</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2050</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Eliciting dose thresholds to food challenge</measure>
      <time_frame>1 year</time_frame>
      <description>Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Food Allergy Quality of Life Questionnaire Child Form</measure>
      <time_frame>1 year</time_frame>
      <description>The number of items found in the child form questionnaire includes 30 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food Allergy Quality of Life Questionnaire Teen Form</measure>
      <time_frame>1 year</time_frame>
      <description>The number of items found in the Teen Form questionnaire includes 26 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food Allergy Quality of Life Questionnaire Adult Form</measure>
      <time_frame>1 year</time_frame>
      <description>The number of items found in the Adult Form questionnaire includes 35 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food Allergy Quality of Life Questionnaire Parent Form</measure>
      <time_frame>1 year</time_frame>
      <description>The number of items found in the Parent Form questionnaire includes 38 items. Food allergy quality of life questionnaire consists of 3 to 4 domains, each question is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin Prick Testing</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by mean wheal size (mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specific IgE</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by ImmunoCap (kU/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Basophil Activation Test</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Tree Nut Allergy</condition>
    <condition>Food Allergy</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Patients with suspected or confirmed food allergy</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Oral food challenge</intervention_name>
      <description>Patients will undergo oral food challenge with increasing amounts of food allergen</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All consecutive patients suspected or confirmed to be food allergic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Suspicion or history of food allergy based on medical history, positive skin prick&#xD;
               test, and/or serum food-specific IgE. A suggestive history is defined as typical&#xD;
               clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting,&#xD;
               dyspnea, wheeze) within 60 minutes of the ingestion of a food.&#xD;
  &#xD;
            2. Ability to discontinue all antihistamines for 1 week before oral food challenge.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous desensitization treatment to a food allergen&#xD;
  &#xD;
            2. Allergies to any component of the oral challenge vehicle&#xD;
  &#xD;
            3. Unstable conditions including uncontrolled asthma or chronic urticaria&#xD;
  &#xD;
            4. Any clinically significant disease/chronic medical condition which may interfere with&#xD;
               study evaluations.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Derek Chu, MD PhD FRCPC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hamilton Health Sciences &amp; McMaster University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Le</last_name>
      <phone>905-525-9140</phone>
      <phone_ext>75153</phone_ext>
      <email>lehea@hhsc.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>McMaster University Medical Centre</name>
        <address>
          <city>Hamilton</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heather Le</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Immunotherapy</keyword>
    <keyword>Food Allergy</keyword>
    <keyword>Diagnosis</keyword>
    <keyword>Prognosis</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>
      <mesh_term>Nut Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Will consider on a case by case basis.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038019
  org study id: NIF-20500
  nct id: NCT06038019
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry.
        The aim is to quantify food allergy thresholds in Canada and their clinical predictors.
  observational model: Other
  time perspective: Prospective
  measure: Eliciting dose thresholds to food challenge
  time frame: 1 year
  description: Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria
  measure: Food Allergy Quality of Life Questionnaire Child Form
  time frame: 1 year
  description: The number of items found in the child form questionnaire includes 30 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
  measure: Food Allergy Quality of Life Questionnaire Teen Form
  time frame: 1 year
  description: The number of items found in the Teen Form questionnaire includes 26 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
  measure: Food Allergy Quality of Life Questionnaire Adult Form
  time frame: 1 year
  description: The number of items found in the Adult Form questionnaire includes 35 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
  measure: Food Allergy Quality of Life Questionnaire Parent Form
  time frame: 1 year
  description: The number of items found in the Parent Form questionnaire includes 38 items. Food allergy quality of life questionnaire consists of 3 to 4 domains, each question is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
  measure: Skin Prick Testing
  time frame: 1 year
  description: Measured by mean wheal size (mm)
  measure: Specific IgE
  time frame: 1 year
  description: Measured by ImmunoCap (kU/L)
  measure: Basophil Activation Test
  time frame: 1 year
  description: Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)
  arm group label: Group 1
  description: Patients with suspected or confirmed food allergy
  intervention type: Diagnostic Test
  intervention name: Oral food challenge
  description: Patients will undergo oral food challenge with increasing amounts of food allergen
  arm group label: Group 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Derek Chu, MD PhD FRCPC
  role: Principal Investigator
  affiliation: Hamilton Health Sciences & McMaster University
  last name: Heather Le
  phone: 905-525-9140
  phone ext: 75153
  email: lehea@hhsc.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Hypersensitivity
  mesh term: Food Hypersensitivity
  mesh term: Nut Hypersensitivity
  sharing ipd: No
  ipd description: Will consider on a case by case basis.