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/NCT05984394</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00804-41</org_study_id>
      <nct_id>NCT05984394</nct_id>
    </id_info>
    <brief_title>Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease</brief_title>
    <acronym>CYTILDASS</acronym>
    <official_title>Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease</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>
        Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and&#xD;
        humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung&#xD;
        disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently,&#xD;
        antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of&#xD;
        patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα,&#xD;
        IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with&#xD;
        progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant&#xD;
        T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1&#xD;
        and Th17 cells may represent a promising treatment in patients AS patients with ILD.&#xD;
  &#xD;
        Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis&#xD;
        are associated with ILD severity at diagnosis and could predict treatment response at 6&#xD;
        months.&#xD;
  &#xD;
        The main objective is to study the correlation between BAL antigen-specific Th1 and Th17&#xD;
        cells at ILD diagnosis and clinical evolution after 6 months of treatment according to&#xD;
        initial ILD severity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>BAL antigen-specific Th1 and Th17 cells</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FVC relative change</measure>
      <time_frame>within 6 months after diagnosis</time_frame>
      <description>Relative change of FVC percentage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>BAL antigen-specific Th1 and Th17 cells</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>FVC percentage at ILD diagnosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC absolute change</measure>
      <time_frame>within 6 months after diagnosis</time_frame>
      <description>Absolute change of FVC percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global activity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>MDAAT score</description>
    </secondary_outcome>
    <other_outcome>
      <measure>BAL ILC</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>BAL ILC percentage among total BAL lymphoid cells</description>
    </other_outcome>
    <other_outcome>
      <measure>BAL MAIT</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>BAL MAIT percentage among total BAL T cells</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Antisynthetase Syndrome</condition>
    <arm_group>
      <arm_group_label>AS patients with ILD</arm_group_label>
      <description>New diagnosis of patients with AS syndrome and ILD</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT</intervention_name>
      <description>BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT</description>
      <arm_group_label>AS patients with ILD</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with AS and ILD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with new diagnosis of AS with ILD&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with ILD differential diagnosis&#xD;
  &#xD;
            -  Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3&#xD;
               months before diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Paul Decker, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Nancy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul Decker, MD</last_name>
      <phone>+33383157240</phone>
      <email>p.decker@chru-nancy.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bernard Bonnotte</name>
        <address>
          <city>Dijon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Bernard Bonnotte, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Julien Campagne</name>
        <address>
          <city>Metz</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Julien Campagne, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Paul Decker</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Decker</last_name>
        <phone>+33383157240</phone>
        <email>p.decker@chru-nancy.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Olivier Benveniste</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Oivier Benveniste, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Loïs Bolko</name>
        <address>
          <city>Reims</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Loïs Bolko, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Alain Meyer</name>
        <address>
          <city>Strasbourg</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Alain Meyer, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
      <investigator_full_name>Paul DECKER, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myositis</mesh_term>
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05984394
  org study id: 2023-A00804-41
  nct id: NCT05984394
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and
        humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung
        disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently,
        antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of
        patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα,
        IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with
        progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant
        T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1
        and Th17 cells may represent a promising treatment in patients AS patients with ILD.
  
        Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis
        are associated with ILD severity at diagnosis and could predict treatment response at 6
        months.
  
        The main objective is to study the correlation between BAL antigen-specific Th1 and Th17
        cells at ILD diagnosis and clinical evolution after 6 months of treatment according to
        initial ILD severity.
  observational model: Cohort
  time perspective: Prospective
  measure: BAL antigen-specific Th1 and Th17 cells
  time frame: baseline (J0)
  description: BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells
  measure: FVC relative change
  time frame: within 6 months after diagnosis
  description: Relative change of FVC percentage
  measure: BAL antigen-specific Th1 and Th17 cells
  time frame: baseline (J0)
  description: BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells
  measure: FVC
  time frame: baseline (J0)
  description: FVC percentage at ILD diagnosis
  measure: FVC absolute change
  time frame: within 6 months after diagnosis
  description: Absolute change of FVC percentage
  measure: Global activity
  time frame: baseline (J0)
  description: MDAAT score
  measure: BAL ILC
  time frame: baseline (J0)
  description: BAL ILC percentage among total BAL lymphoid cells
  measure: BAL MAIT
  time frame: baseline (J0)
  description: BAL MAIT percentage among total BAL T cells
  arm group label: AS patients with ILD
  description: New diagnosis of patients with AS syndrome and ILD
  intervention type: Diagnostic Test
  intervention name: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
  description: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
  arm group label: AS patients with ILD
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Paul Decker, MD
  role: Principal Investigator
  affiliation: CHU Nancy
  last name: Paul Decker, MD
  phone: +33383157240
  email: p.decker@chru-nancy.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
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  contact: 
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  contact: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Central Hospital, Nancy, France
  investigator full name: Paul DECKER, MD
  investigator title: Principal Investigator
  mesh term: Myositis
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  mesh term: Syndrome
  sharing ipd: No