<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/NCT03791034</url>
  </required_header>
  <id_info>
    <org_study_id>2017-08-041-003</org_study_id>
    <nct_id>NCT03791034</nct_id>
  </id_info>
  <brief_title>Cell Free DNA for the Diagnosis and Treatment in Early NSCLC</brief_title>
  <official_title>Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guardant Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</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>
      The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA&#xD;
      (cfDNA) can aid screening of recurrence after complete resection of early stage non-small&#xD;
      cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During evolution of primary tumor, tumor cells can be released into the bloodstream. It has&#xD;
      also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or&#xD;
      necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they&#xD;
      suggested that cfDNA could detect recurrence of cancer several months earlier than the&#xD;
      conventional follow up studies. Following several reports have suggested that cfDNA can&#xD;
      invade host cells and alter host cell biology to cause cancer metastasis.&#xD;
&#xD;
      In this regard, we will collect from non-small cell lung cancer patients cohort who underwent&#xD;
      curative resection, and will evaluate whether peripheral cfDNA can aid early detection of&#xD;
      cancer recurrence. We will also study the genomic signature of cfDNA to assess the&#xD;
      relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>24 months</time_frame>
    <description>Recurrence of primary tumor documented by diagnostic imaging with or without biopsy</description>
  </primary_outcome>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will collect peripheral blood cell-free tumor DNA serially in non-small cell lung cancer&#xD;
      cancer patients.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        non-small cell lung cancer patients who undergone curative surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects need to sign the informed consent form&#xD;
&#xD;
          -  All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed&#xD;
             pathologically preoperatively.&#xD;
&#xD;
          -  Non-small cell lung cancer have to confirmed pathologically after operation&#xD;
&#xD;
          -  Clinical stage I - IIIA by AJCC 7th staging system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer&#xD;
&#xD;
          -  Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine&#xD;
             cervix with 3 years before enrollment&#xD;
&#xD;
          -  Recurrent lung cancer&#xD;
&#xD;
          -  Stage IIIB, IV by AJCC 7th staging system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jhingook Kim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jhingook Kim, MD</last_name>
    <phone>+82-2-3410-3483</phone>
    <email>jkimsmc@skku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jhingook Kim, MD</last_name>
      <phone>+82-2-3410-3483</phone>
      <email>jkimsmc@skku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>May 9, 2021</last_update_submitted>
  <last_update_submitted_qc>May 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jhingook Kim, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Non-small cell lung cancer</keyword>
  <keyword>Recurrence</keyword>
  <keyword>cfDNA</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/NCT03791034
org study id: 2017-08-041-003
nct id: NCT03791034
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA
      (cfDNA) can aid screening of recurrence after complete resection of early stage non-small
      cell lung cancer.
During evolution of primary tumor, tumor cells can be released into the bloodstream. It has
      also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or
      necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they
      suggested that cfDNA could detect recurrence of cancer several months earlier than the
      conventional follow up studies. Following several reports have suggested that cfDNA can
      invade host cells and alter host cell biology to cause cancer metastasis.

      In this regard, we will collect from non-small cell lung cancer patients cohort who underwent
      curative resection, and will evaluate whether peripheral cfDNA can aid early detection of
      cancer recurrence. We will also study the genomic signature of cfDNA to assess the
      relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.
observational model: Cohort
time perspective: Prospective
measure: Recurrence
time frame: 24 months
description: Recurrence of primary tumor documented by diagnostic imaging with or without biopsy
We will collect peripheral blood cell-free tumor DNA serially in non-small cell lung cancer
      cancer patients.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jhingook Kim, MD
role: Study Chair
affiliation: Samsung Medical Center
last name: Jhingook Kim, MD
phone: +82-2-3410-3483
email: jkimsmc@skku.edu
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jhingook Kim, MD
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No