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/NCT05989399</url>
    </required_header>
    <id_info>
      <org_study_id>2023PI083</org_study_id>
      <nct_id>NCT05989399</nct_id>
    </id_info>
    <brief_title>Evaluation of Circulating Neutrophils in Antisynthetase Syndrome</brief_title>
    <acronym>NEUTROSAS2</acronym>
    <official_title>Evaluation of Circulating Neutrophils in Antisynthetase Syndrome: a Multicenter Retrospective Study</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 (ASyS) is a rare and heteregeneous overlapping connective tissue&#xD;
        disease, characterized by myositis, interstitial lung disease (ILD), joint involvement,&#xD;
        Raynaud's phenomenon and cutaneous manifestations (&quot;mechanic's hands&quot;). Over 50% of patients&#xD;
        develop ILD, which is the leading cause of death.&#xD;
  &#xD;
        The role of neutrophils - innate immune cells involved in inflammatory processes and induced&#xD;
        in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role&#xD;
        of neutrophils has been described during idiopathic inflammatory myopathies, with an increase&#xD;
        of netosis correlated with disease activity and muscle damage. During ASyS, a higher number&#xD;
        of alveolar neutrophils has been observed in patients with rapidly progressive ILD.&#xD;
  &#xD;
        There are few data on the specific evaluation of circulating neutrophils in ASyS.&#xD;
        Investigators suppose that circulating neutrophils level could represent a simple and&#xD;
        accessible severity biomarker in patients with ASyS.&#xD;
  &#xD;
        The main objective is to evaluate the diagnostic performance of the circulating neutrophils&#xD;
        level (&gt; 7000/mm3) at diagnosis on ASyS severity.&#xD;
  &#xD;
        The secondary objectives are:&#xD;
  &#xD;
          -  to define a threshold for circulating neutrophils levels at diagnosis allowing to&#xD;
             predict ASyS severity and to assess the diagnostic performance of this threshold.&#xD;
  &#xD;
          -  to study the correlation between the level of circulating neutrophils and ASyS severity&#xD;
             at diagnosis of the disease.&#xD;
  &#xD;
          -  to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of&#xD;
             treatment.&#xD;
  &#xD;
          -  to compare patients characteristics according to ASyS severity at diagnosis.&#xD;
  &#xD;
          -  to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in&#xD;
             patients with ILD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>circulating neutrophils level &gt; 7000/mm3</measure>
      <time_frame>baseline (J0)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>number of patients with global severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>global severity defined as presence of severe ILD (PaO2 &lt; 600 mmHg or rapidly progressive ILD), and/or presence of severe myositis (bedrest, or MMT8 score &lt; 30, or MRC muscle testing &lt; 3/5, or swallowing disorers, or dysphagia) and/or presence of myocarditis on cardiac MRI</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>circulating neutrophils level</measure>
      <time_frame>baseline (J0)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>FVC percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DLCO</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>DLCO percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>grade of MRC muscle testing</measure>
      <time_frame>baseline (J0)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CK level</measure>
      <time_frame>baseline (J0)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>circulating neutrophils level</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BAL fluid neutrophils level</measure>
      <time_frame>baseline (J0)</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Antisynthetase Syndrome</condition>
    <arm_group>
      <arm_group_label>ASyS patients</arm_group_label>
      <description>Patients with antisynthetase syndrome</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>circulating neutrophils</intervention_name>
      <description>evaluation of circulating neutrophils level</description>
      <arm_group_label>ASyS patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with ASyS diagnosis between January 2010 and December 2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with ASyS diagnosis according to Connors criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active infection at ASyS diagnosis&#xD;
  &#xD;
            -  Evolutive cancer at ASyS diagnosis&#xD;
  &#xD;
            -  Corticosteroid therapy initiation before circulating neutrophils evaluation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>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/NCT05989399
  org study id: 2023PI083
  nct id: NCT05989399
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue
        disease, characterized by myositis, interstitial lung disease (ILD), joint involvement,
        Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients
        develop ILD, which is the leading cause of death.
  
        The role of neutrophils - innate immune cells involved in inflammatory processes and induced
        in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role
        of neutrophils has been described during idiopathic inflammatory myopathies, with an increase
        of netosis correlated with disease activity and muscle damage. During ASyS, a higher number
        of alveolar neutrophils has been observed in patients with rapidly progressive ILD.
  
        There are few data on the specific evaluation of circulating neutrophils in ASyS.
        Investigators suppose that circulating neutrophils level could represent a simple and
        accessible severity biomarker in patients with ASyS.
  
        The main objective is to evaluate the diagnostic performance of the circulating neutrophils
        level (> 7000/mm3) at diagnosis on ASyS severity.
  
        The secondary objectives are:
  
          -  to define a threshold for circulating neutrophils levels at diagnosis allowing to
             predict ASyS severity and to assess the diagnostic performance of this threshold.
  
          -  to study the correlation between the level of circulating neutrophils and ASyS severity
             at diagnosis of the disease.
  
          -  to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of
             treatment.
  
          -  to compare patients characteristics according to ASyS severity at diagnosis.
  
          -  to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in
             patients with ILD.
  observational model: Cohort
  time perspective: Retrospective
  measure: circulating neutrophils level > 7000/mm3
  time frame: baseline (J0)
  measure: number of patients with global severity
  time frame: baseline (J0)
  description: global severity defined as presence of severe ILD (PaO2 < 600 mmHg or rapidly progressive ILD), and/or presence of severe myositis (bedrest, or MMT8 score < 30, or MRC muscle testing < 3/5, or swallowing disorers, or dysphagia) and/or presence of myocarditis on cardiac MRI
  measure: circulating neutrophils level
  time frame: baseline (J0)
  measure: FVC
  time frame: baseline (J0)
  description: FVC percentage
  measure: DLCO
  time frame: baseline (J0)
  description: DLCO percentage
  measure: grade of MRC muscle testing
  time frame: baseline (J0)
  measure: CK level
  time frame: baseline (J0)
  measure: circulating neutrophils level
  time frame: 12 months
  measure: BAL fluid neutrophils level
  time frame: baseline (J0)
  arm group label: ASyS patients
  description: Patients with antisynthetase syndrome
  intervention type: Diagnostic Test
  intervention name: circulating neutrophils
  description: evaluation of circulating neutrophils level
  arm group label: ASyS patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Paul Decker, MD
  role: Principal Investigator
  affiliation: CHU Nancy
  last name: Paul Decker, MD
  phone: +33383157240
  email: p.decker@chru-nancy.fr
  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: Syndrome
  sharing ipd: No