<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/NCT02991924</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2016-0156</org_study_id>
    <nct_id>NCT02991924</nct_id>
  </id_info>
  <brief_title>Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer</brief_title>
  <official_title>Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate risk factors for mediastinal lymph node&#xD;
      metastasis in potentially operable non-small cell lung cancer in order to find indications&#xD;
      for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound&#xD;
      guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with&#xD;
      bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging.&#xD;
      CT and PET/CT findings, histologic types and other risk factors will be analyzed. The&#xD;
      investigators develop the prediction method for mediastinal metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Years</target_duration>
  <primary_outcome>
    <measure>Relative risk of risk factors for mediastinal metastasis</measure>
    <time_frame>When confirmative diagnosis are available in all subjects ;3 years</time_frame>
    <description>risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic values of endoscopic staging</measure>
    <time_frame>When confirmative diagnosis are available in all subjects ;3 years</time_frame>
    <description>sensitivity, negative predictive value, accuracy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>After the diagnosis ; 7 years</time_frame>
    <description>survival after lung cancer treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molecular test</measure>
    <time_frame>for each subject; up to 60 days, available in all subjects ; 3 years</time_frame>
    <description>EGFR, ALK etc</description>
  </secondary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Non-small cell lung cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Potentially operable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  M1 disease&#xD;
&#xD;
          -  Inoperable T4 disease&#xD;
&#xD;
          -  Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible&#xD;
             on chest CT&#xD;
&#xD;
          -  Confirmed supraclavicular lymph node metastasis&#xD;
&#xD;
          -  Pancoast tumours&#xD;
&#xD;
          -  T1 ground glass opacity nodule (with solid part 1&lt;cm)&#xD;
&#xD;
          -  Solid T1 (1&lt;cm)N0 M0 by CT &amp; PET/CT&#xD;
&#xD;
          -  Inoperable patients (after evaluating medical and surgical operability)&#xD;
&#xD;
          -  Patients who refused surgical treatment&#xD;
&#xD;
          -  Contraindications for bronchoscopy&#xD;
&#xD;
          -  Drug reaction to lidocaine, midazolam, fentanyl&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Hwangbo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center (NCC) Korea</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-do</state>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Bin Hwangbo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>endobronchial ultrasound</keyword>
  <keyword>EBUS-TBNA</keyword>
  <keyword>lung cancer</keyword>
  <keyword>staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02991924
org study id: NCC2016-0156
nct id: NCT02991924
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate risk factors for mediastinal lymph node
      metastasis in potentially operable non-small cell lung cancer in order to find indications
      for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound
      guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with
      bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging.
      CT and PET/CT findings, histologic types and other risk factors will be analyzed. The
      investigators develop the prediction method for mediastinal metastasis.
observational model: Case-Only
time perspective: Prospective
measure: Relative risk of risk factors for mediastinal metastasis
time frame: When confirmative diagnosis are available in all subjects ;3 years
description: risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.
measure: Diagnostic values of endoscopic staging
time frame: When confirmative diagnosis are available in all subjects ;3 years
description: sensitivity, negative predictive value, accuracy
measure: Survival
time frame: After the diagnosis ; 7 years
description: survival after lung cancer treatment
measure: Molecular test
time frame: for each subject; up to 60 days, available in all subjects ; 3 years
description: EGFR, ALK etc
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bin Hwangbo, PhD
role: Principal Investigator
affiliation: National Cancer Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Bin Hwangbo
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No