<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/NCT03235765</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH-17-01</org_study_id>
    <nct_id>NCT03235765</nct_id>
  </id_info>
  <brief_title>Cancer Panel From Blood of Lung Cancer Patients</brief_title>
  <acronym>CAPABLE</acronym>
  <official_title>Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MACROGEN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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>
      Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of&#xD;
      patients is rapidly becoming established as a useful source of information to aid clinical&#xD;
      decision-making. This study is aimed to to compare concordance rate between tissue based&#xD;
      cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by&#xD;
      NGS technique).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is comprised of two cohorts as below:&#xD;
&#xD;
      Cohort A: inoperable, untreated, non-small cell lung cancer patients&#xD;
&#xD;
      Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents&#xD;
      including immune checkpoint inhibitors&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Anticipated">March 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Concordance rate</measure>
    <time_frame>an average of one year</time_frame>
    <description>Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>an average of one year</time_frame>
    <description>To evaluate prognostic role of ctDNA concentration in NSCLC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of actionable genomic change</measure>
    <time_frame>an average of one year</time_frame>
    <description>To determine the frequency of actionable oncogenic genes in NSCLC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival by treatment</measure>
    <time_frame>an average of one year</time_frame>
    <description>To evaluate the survival of patients treated with genotype-directed therapy in daily practice</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Non Small Cell Lung Cancer Metastatic</condition>
  <condition>Non Small Cell Lung Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MACROGEN Pan Cancer Panel (Tier 2)</intervention_name>
    <description>This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cancer panel analysis will be done with patients tumro tissue and ctDNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inoperable non-small cell lung cancer with two cohorts as below:&#xD;
&#xD;
          1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung&#xD;
             cancer and planned to receive first line chemotherapy&#xD;
&#xD;
          2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been&#xD;
             receiving molecular targeted therapy, including immune checkpoint inhibitor, and have&#xD;
             tumor shrinkage with the agent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent prior to any study specific procedures, sampling, and&#xD;
             analyses&#xD;
&#xD;
          -  Pathologically confirmed non-small cell lung cancer&#xD;
&#xD;
          -  Male or female, aged at least 20 years&#xD;
&#xD;
          -  Matches one of two criteria :&#xD;
&#xD;
               1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell&#xD;
                  lung cancer and planned to receive first line chemotherapy&#xD;
&#xD;
               2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have&#xD;
                  been receiving molecular targeted therapy, including immune checkpoint inhibitor,&#xD;
                  and have tumor shrinkage with the agent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concurrent and/or other active malignancy that has required treatment within 3&#xD;
             years&#xD;
&#xD;
          -  Patients with mixed small cell histology&#xD;
&#xD;
          -  Life expectancy less than 3 months&#xD;
&#xD;
          -  Insufficient tissue for NGS test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Jong-Seok Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>Cancer panel</keyword>
  <keyword>NGS</keyword>
  <keyword>Actionable mutation</keyword>
  <keyword>Immune checkpoint inhibitor</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>Undecided</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/NCT03235765
org study id: SNUBH-17-01
nct id: NCT03235765
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of
      patients is rapidly becoming established as a useful source of information to aid clinical
      decision-making. This study is aimed to to compare concordance rate between tissue based
      cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by
      NGS technique).
This study is comprised of two cohorts as below:

      Cohort A: inoperable, untreated, non-small cell lung cancer patients

      Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents
      including immune checkpoint inhibitors
observational model: Cohort
time perspective: Prospective
measure: Concordance rate
time frame: an average of one year
description: Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA
measure: Overall survival
time frame: an average of one year
description: To evaluate prognostic role of ctDNA concentration in NSCLC
measure: Frequency of actionable genomic change
time frame: an average of one year
description: To determine the frequency of actionable oncogenic genes in NSCLC
measure: Overall survival by treatment
time frame: an average of one year
description: To evaluate the survival of patients treated with genotype-directed therapy in daily practice
arm group label: Cohort A
description: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy
arm group label: Cohort B
description: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.
intervention type: Diagnostic Test
intervention name: MACROGEN Pan Cancer Panel (Tier 2)
description: This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.
arm group label: Cohort A
arm group label: Cohort B
Cancer panel analysis will be done with patients tumro tissue and ctDNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Jong-Seok Lee
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided