<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/NCT04413149</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-ANCA-positive ILD</org_study_id>
    <nct_id>NCT04413149</nct_id>
  </id_info>
  <brief_title>Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.</brief_title>
  <official_title>Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.</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>
    <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>
      The purpose of this study is to investigate the clinical features and long-term outcome of&#xD;
      anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and&#xD;
      assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated&#xD;
      ANCA-positive idiopathic interstitial pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ILD patients with serum ANCA-positivity were enrolled in this study.&#xD;
&#xD;
        1. Baseline data collection:&#xD;
&#xD;
             1. Demographics information (age, gender)&#xD;
&#xD;
             2. Clinical course&#xD;
&#xD;
             3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing&#xD;
                fingers, mechanics hand)&#xD;
&#xD;
             4. Laboratory findings (blood and urine routine, liver and renal function tests,&#xD;
                erythrocyte sedimentation rate, C reactive protein)&#xD;
&#xD;
             5. Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP),&#xD;
                Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)&#xD;
&#xD;
             6. Systemic manifestation if diagnosed as systemic vasculitis&#xD;
&#xD;
             7. Pulmonary function tests (ventilation and diffusion capacity test)&#xD;
&#xD;
             8. Chest high-resolution computed tomography (HRCT)&#xD;
&#xD;
        2. Treatment: treatment will be given according to the experience of each pulmonologist.&#xD;
&#xD;
        3. Follow-up:&#xD;
&#xD;
             1. Patients were followed up at least once a year and basic laboratory tests,&#xD;
                serologic autoantibodies, pulmonary function test and chest HRCT were evaluated&#xD;
                routinely&#xD;
&#xD;
             2. Follow-up end point was April 2019.&#xD;
&#xD;
        4. Outcome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death from all cause</measure>
    <time_frame>From baseline until the date of death from all cause, up to 5 years</time_frame>
    <description>Death from all cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who underwent lung transplantation</measure>
    <time_frame>From baseline until the date of transplantation, up to 5 years</time_frame>
    <description>Number of patients who underwent lung transplantation</description>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <condition>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.&#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;
          -  Have available ANCA testing results during the first visit and follow-up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Connective tissue disease associated ILD&#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>Study Chair</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>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interstitial Lung Disease</keyword>
  <keyword>Anti-Neutrophil Cytoplasmic Antibody</keyword>
  <keyword>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</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>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 14, 2020</submitted>
    <returned>July 29, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04413149
org study id: PUMCH-ANCA-positive ILD
nct id: NCT04413149
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the clinical features and long-term outcome of
      anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and
      assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated
      ANCA-positive idiopathic interstitial pneumonia.
ILD patients with serum ANCA-positivity were enrolled in this study.

        1. Baseline data collection:

             1. Demographics information (age, gender)

             2. Clinical course

             3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing
                fingers, mechanics hand)

             4. Laboratory findings (blood and urine routine, liver and renal function tests,
                erythrocyte sedimentation rate, C reactive protein)

             5. Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP),
                Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)

             6. Systemic manifestation if diagnosed as systemic vasculitis

             7. Pulmonary function tests (ventilation and diffusion capacity test)

             8. Chest high-resolution computed tomography (HRCT)

        2. Treatment: treatment will be given according to the experience of each pulmonologist.

        3. Follow-up:

             1. Patients were followed up at least once a year and basic laboratory tests,
                serologic autoantibodies, pulmonary function test and chest HRCT were evaluated
                routinely

             2. Follow-up end point was April 2019.

        4. Outcome
observational model: Case-Only
time perspective: Retrospective
measure: Death from all cause
time frame: From baseline until the date of death from all cause, up to 5 years
description: Death from all cause
measure: Number of patients who underwent lung transplantation
time frame: From baseline until the date of transplantation, up to 5 years
description: Number of patients who underwent lung transplantation
serum
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: Study Chair
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
mesh term: Vasculitis
mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
submitted: July 14, 2020
returned: July 29, 2020