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/NCT06007040</url>
    </required_header>
    <id_info>
      <org_study_id>PUMCH-PCCM-ILD</org_study_id>
      <nct_id>NCT06007040</nct_id>
    </id_info>
    <brief_title>Interstitial Lung Disease Associated</brief_title>
    <official_title>Interstitial Lung Disease Associated</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD&#xD;
        spectrum share the same clinical manifestations and outcome with CTD feature disease&#xD;
        spectrum.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia&#xD;
        during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between&#xD;
        January 2012 and December 2021.&#xD;
  &#xD;
          1. Baseline data collection:&#xD;
  &#xD;
               1. Baseline information at the time of initial diagnosis was obtained, and the&#xD;
                  following items were analyzed: demographic information (age, gender), clinical&#xD;
                  course, clinical symptoms and signs, laboratory findings [routine blood,&#xD;
                  erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP),&#xD;
                  rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests&#xD;
                  (PFTs), and chest HRCT scans.&#xD;
  &#xD;
               2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.&#xD;
  &#xD;
               3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists.&#xD;
                  The HRCT scans were analyzed for the following characteristics: ground-glass&#xD;
                  opacities, reticular patterns, honeycombing, traction bronchiectasis.&#xD;
  &#xD;
               4. Spirometry was performed according to standardized guidelines. PFTs results were&#xD;
                  expressed as percentages of the predicted values, thereby correcting for age,&#xD;
                  gender and bodyweight.&#xD;
  &#xD;
          2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine,&#xD;
             cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to&#xD;
             the time of patient's last visit or time of death, and the outcomes were defined as&#xD;
             death from all causes.&#xD;
  &#xD;
          3. Outcome&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2012</start_date>
    <completion_date type="Actual">December 2021</completion_date>
    <primary_completion_date type="Actual">December 2021</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>All-cause mortality</measure>
      <time_frame>From baseline until the date of death from all cause, up to 5 years</time_frame>
      <description>death from all causes</description>
    </primary_outcome>
    <enrollment type="Actual">1000</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Interstitial pneumonia based on clinical symptoms and radiologic features, with or without&#xD;
          histopathologic results.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females&#xD;
  &#xD;
            -  Aged from 18 to 85 years with informed consent&#xD;
  &#xD;
            -  Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or&#xD;
               without histopathologic results&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ILD induced by drug, environment, or occupational exposure&#xD;
  &#xD;
            -  Hypersensitivity pneumonitis and sarcoidosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Juhong Shi, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Interstitial lung disease, ANCA, CTD, IPAF, IIP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</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/NCT06007040
  org study id: PUMCH-PCCM-ILD
  nct id: NCT06007040
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD
        spectrum share the same clinical manifestations and outcome with CTD feature disease
        spectrum.
  We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia
        during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between
        January 2012 and December 2021.
  
          1. Baseline data collection:
  
               1. Baseline information at the time of initial diagnosis was obtained, and the
                  following items were analyzed: demographic information (age, gender), clinical
                  course, clinical symptoms and signs, laboratory findings [routine blood,
                  erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP),
                  rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests
                  (PFTs), and chest HRCT scans.
  
               2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.
  
               3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists.
                  The HRCT scans were analyzed for the following characteristics: ground-glass
                  opacities, reticular patterns, honeycombing, traction bronchiectasis.
  
               4. Spirometry was performed according to standardized guidelines. PFTs results were
                  expressed as percentages of the predicted values, thereby correcting for age,
                  gender and bodyweight.
  
          2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine,
             cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to
             the time of patient's last visit or time of death, and the outcomes were defined as
             death from all causes.
  
          3. Outcome
  observational model: Cohort
  time perspective: Retrospective
  measure: All-cause mortality
  time frame: From baseline until the date of death from all cause, up to 5 years
  description: death from all causes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Juhong Shi, M.D
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: No