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/NCT05983978</url>
    </required_header>
    <id_info>
      <org_study_id>PI-5473</org_study_id>
      <nct_id>NCT05983978</nct_id>
    </id_info>
    <brief_title>No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays</brief_title>
    <official_title>No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto de Investigación Hospital Universitario La Paz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hospital Universitari Mutua Terrassa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Sant Joan de Deu</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitario Ramon y Cajal</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitario Lucus Augusti</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitario Fundación Jiménez Díaz</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Instituto de Investigación Sanitaria Hospital Clínico San Carlos</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Instituto de Investigación Hospital Universitario La Paz</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>
        The main objective of this multicenter and observational study is to define the optimal&#xD;
        threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody&#xD;
        assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.&#xD;
  &#xD;
        The main questions to be answered are:&#xD;
  &#xD;
          -  Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful&#xD;
             in all anti-tTG IgA assays?&#xD;
  &#xD;
          -  Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in&#xD;
             all the evaluated assays?&#xD;
  &#xD;
          -  Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet&#xD;
             (GFD) similar across the different assays included in the study?&#xD;
  &#xD;
        This is a prospective multicenter study that will enroll pediatric and adult patients with&#xD;
        new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for&#xD;
        the determination of anti-tTG-IgA according to the local methodology (participating hospital)&#xD;
        and by the anti-tTG IgA assays most commonly used in our country, which will be centralized&#xD;
        in the same reference center (Hospital Universitario La Paz).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 2, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Anti-transglutaminase-IgA titer</measure>
      <time_frame>The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).</time_frame>
      <description>To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.</description>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Celiac Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients will be consecutively recruited from the gastroenterology departments (either&#xD;
          adult or pediatric) of the participating hospitals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients, on gluten-containing diet, with TGt-IgA antibodies &gt; Upper Limit of Normal&#xD;
               (ULN) and intestinal biopsy confirming celiac disease (CD).&#xD;
  &#xD;
            -  Patients with TCRγδ+ &gt;10% combined with decrease NK-like intraepithelial lymphocytes&#xD;
               in the intestinal epithelium.&#xD;
  &#xD;
            -  Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies &gt;10xULN) without&#xD;
               duodenal biopsy performed.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patients already diagnosed with CD.&#xD;
  &#xD;
            -  Patients who refused duodenal biopsy.&#xD;
  &#xD;
            -  Patients with primary or secondary immunodeficiencies.&#xD;
  &#xD;
            -  Patients with malignancy.&#xD;
  &#xD;
            -  Recruited patients whose remaining serum cannot be sent to the reference centre, whose&#xD;
               biopsies are of poor quality or who nod not sign the informed consent from.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marta Molero-Luis, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Universitario La Paz</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marta Molero-Luis, Dr</last_name>
      <phone>0034660065755</phone>
      <email>marta.molero@salud.madrid.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Concepción Núñez Pardo de Vera, Dr</last_name>
      <email>conchita.npardo@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Mutua Terrassa</name>
        <address>
          <city>Terrassa</city>
          <state>Barcelona</state>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Albert Martin Cardona</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Sant Joan de Deu</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elisabet Poyatos</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Lucus Augusti</name>
        <address>
          <city>Lugo</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Julia María Cabo del Riego</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario La Paz</name>
        <address>
          <city>Madrid</city>
          <zip>28046</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marta Molero-Luis, Dr</last_name>
        <email>marta.molero@salud.madrid.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Ramon y Cajal</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Garbiñe Roy Ariño</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Fundación Jimenez Diaz</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>María José Martínez Becerra</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto de Investigación Hospital Universitario La Paz</investigator_affiliation>
      <investigator_full_name>Marta Molero</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>anti-transglutaminase IgA</keyword>
    <keyword>no-biopsy approach</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT05983978
  org study id: PI-5473
  nct id: NCT05983978
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this multicenter and observational study is to define the optimal
        threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody
        assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.
  
        The main questions to be answered are:
  
          -  Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful
             in all anti-tTG IgA assays?
  
          -  Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in
             all the evaluated assays?
  
          -  Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet
             (GFD) similar across the different assays included in the study?
  
        This is a prospective multicenter study that will enroll pediatric and adult patients with
        new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for
        the determination of anti-tTG-IgA according to the local methodology (participating hospital)
        and by the anti-tTG IgA assays most commonly used in our country, which will be centralized
        in the same reference center (Hospital Universitario La Paz).
  observational model: Cohort
  time perspective: Prospective
  measure: Anti-transglutaminase-IgA titer
  time frame: The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).
  description: To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Marta Molero-Luis, Dr
  role: Principal Investigator
  affiliation: Hospital Universitario La Paz
  last name: Marta Molero-Luis, Dr
  phone: 0034660065755
  email: marta.molero@salud.madrid.org
  last name: Concepción Núñez Pardo de Vera, Dr
  email: conchita.npardo@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Instituto de Investigación Hospital Universitario La Paz
  investigator full name: Marta Molero
  investigator title: Doctor
  mesh term: Celiac Disease