<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/NCT03238989</url>
  </required_header>
  <id_info>
    <org_study_id>ILD Registry</org_study_id>
    <nct_id>NCT03238989</nct_id>
  </id_info>
  <brief_title>Interstitial Lung Disease Registry Construction</brief_title>
  <acronym>ILD Registry</acronym>
  <official_title>Interstitial Lung Disease Registry Construction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      The purpose of this study is investigating the clinical course, treatment course, and&#xD;
      prognosis of patients with interstitial lung disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the&#xD;
      lung.&#xD;
&#xD;
      It can be broadly classified into lung disease secondary to the cause of systemic disease or&#xD;
      drug, and lung disease whose cause is unknown, and the latter is known as idiopathic&#xD;
      interstitial pneumonia.&#xD;
&#xD;
      Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory&#xD;
      response and fibrosis reaction, and the cause of the onset is not accurately known yet, also&#xD;
      there is no effective treatment.&#xD;
&#xD;
      Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very&#xD;
      slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.&#xD;
&#xD;
      Therefore, it is important to collect data prospectively for changes in clinical features,&#xD;
      pulmonary function, imaging findings, and quality of life of these patients.&#xD;
&#xD;
      A prospective study of idiopathic interstitial pneumonia will provide important information&#xD;
      on the clinical characteristics and admission history of patients with idiopathic&#xD;
      interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve&#xD;
      as the basis for further prospective observational studies.&#xD;
&#xD;
      The aim of this study is to establish the registry of patients with interstitial lung disease&#xD;
      and to prospectively review the clinical features and progression of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 5, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>St George's Respiratory Questionnaire(SGRQ)</measure>
    <time_frame>at baseline, every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in clinical symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modified Medical Research Council (mMRC) dyspnea scale</measure>
    <time_frame>at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in clinical symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Borg dyspnea scale</measure>
    <time_frame>at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in clinical symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital anxiety and depression score(HADS)</measure>
    <time_frame>at baseline, every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in clinical symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>chest X-ray</measure>
    <time_frame>at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in chest radiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chest CT</measure>
    <time_frame>at baseline, every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in chest radiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Paranasal sinus X-ray(PNS series)</measure>
    <time_frame>at baseline</time_frame>
    <description>baseline PNS X-ray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram(ECG)</measure>
    <time_frame>at baseline</time_frame>
    <description>baseline ECG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary function test with bronchodilator response test(PFT+BDR)</measure>
    <time_frame>at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in lung function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diffusing capacity of the lungs for carbon monoxide(DLCO)</measure>
    <time_frame>at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years</time_frame>
    <description>monitoring changes in lung function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total lung capacity(TLC)</measure>
    <time_frame>at baseline</time_frame>
    <description>monitoring changes in lung function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bronchoscopic alveolar lavage(BAL)</measure>
    <time_frame>at baseline</time_frame>
    <description>for diagnostic purposes if necessary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Video-assisted thoracoscopic surgery(VATS) lung biopsy</measure>
    <time_frame>at baseline</time_frame>
    <description>for diagnostic purposes if necessary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>echocardiography</measure>
    <time_frame>at baseline</time_frame>
    <description>additionally tested at acute exacerbation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>arterial blood gas analysis(ABGA)</measure>
    <time_frame>at baseline</time_frame>
    <description>additionally tested at acute exacerbation</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>monitoring changes in clinical symptoms, pulmonary function, and chest radiography</intervention_name>
    <description>For patients with interstitial lung disease, the investigators regularly monitor changes in clinical symptoms, pulmonary function, and chest radiography after basic questionnaire on symptoms, lifestyle, depression, and quality of life.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        outpatient, ward&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 20 years diagnosed with interstitial lung disease&#xD;
&#xD;
          -  Diagnostic criteria for interstitial lung disease. If one of the following is met:&#xD;
&#xD;
               1. clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest&#xD;
                  CT findings with honeycomb cysts and fibrosis and reasonable clinical signs&#xD;
&#xD;
               2. suspected interstitial pneumonia, or confirmed by biopsy with no evidence of&#xD;
                  infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic&#xD;
                  organizing pneumonia(COP), unclassified fibrosis&#xD;
&#xD;
               3. interstitial lung disease suspects with underlying rheumatic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No specific criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Choi Sun Mi</last_name>
    <phone>02-2072-4915</phone>
    <email>sunmich81@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>PARK HEEMOON</last_name>
    <email>coramdeo33@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Choi Sun Mi</last_name>
      <phone>02-2072-4915</phone>
      <email>sunmich81@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>PARK HEEMOON</last_name>
      <email>coramdeo33@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Sun Mi Choi</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Interstitial lung disease</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>
  <!-- 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/NCT03238989
org study id: ILD Registry
nct id: NCT03238989
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is investigating the clinical course, treatment course, and
      prognosis of patients with interstitial lung disease.
Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the
      lung.

      It can be broadly classified into lung disease secondary to the cause of systemic disease or
      drug, and lung disease whose cause is unknown, and the latter is known as idiopathic
      interstitial pneumonia.

      Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory
      response and fibrosis reaction, and the cause of the onset is not accurately known yet, also
      there is no effective treatment.

      Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very
      slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.

      Therefore, it is important to collect data prospectively for changes in clinical features,
      pulmonary function, imaging findings, and quality of life of these patients.

      A prospective study of idiopathic interstitial pneumonia will provide important information
      on the clinical characteristics and admission history of patients with idiopathic
      interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve
      as the basis for further prospective observational studies.

      The aim of this study is to establish the registry of patients with interstitial lung disease
      and to prospectively review the clinical features and progression of the patients.
observational model: Cohort
time perspective: Prospective
measure: St George's Respiratory Questionnaire(SGRQ)
time frame: at baseline, every 1 year through study completion for 10 years
description: monitoring changes in clinical symptoms
measure: modified Medical Research Council (mMRC) dyspnea scale
time frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
description: monitoring changes in clinical symptoms
measure: Borg dyspnea scale
time frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
description: monitoring changes in clinical symptoms
measure: Hospital anxiety and depression score(HADS)
time frame: at baseline, every 1 year through study completion for 10 years
description: monitoring changes in clinical symptoms
measure: chest X-ray
time frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
description: monitoring changes in chest radiography
measure: Chest CT
time frame: at baseline, every 1 year through study completion for 10 years
description: monitoring changes in chest radiography
measure: Paranasal sinus X-ray(PNS series)
time frame: at baseline
description: baseline PNS X-ray
measure: Electrocardiogram(ECG)
time frame: at baseline
description: baseline ECG
measure: Pulmonary function test with bronchodilator response test(PFT+BDR)
time frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
description: monitoring changes in lung function
measure: Diffusing capacity of the lungs for carbon monoxide(DLCO)
time frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
description: monitoring changes in lung function
measure: total lung capacity(TLC)
time frame: at baseline
description: monitoring changes in lung function
measure: Bronchoscopic alveolar lavage(BAL)
time frame: at baseline
description: for diagnostic purposes if necessary
measure: Video-assisted thoracoscopic surgery(VATS) lung biopsy
time frame: at baseline
description: for diagnostic purposes if necessary
measure: echocardiography
time frame: at baseline
description: additionally tested at acute exacerbation
measure: arterial blood gas analysis(ABGA)
time frame: at baseline
description: additionally tested at acute exacerbation
intervention type: Other
intervention name: monitoring changes in clinical symptoms, pulmonary function, and chest radiography
description: For patients with interstitial lung disease, the investigators regularly monitor changes in clinical symptoms, pulmonary function, and chest radiography after basic questionnaire on symptoms, lifestyle, depression, and quality of life.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: Choi Sun Mi
phone: 02-2072-4915
email: sunmich81@gmail.com
last name: PARK HEEMOON
email: coramdeo33@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Sun Mi Choi
investigator title: Assistant professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial