<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/NCT03301961</url>
  </required_header>
  <id_info>
    <org_study_id>PTHO1701</org_study_id>
    <nct_id>NCT03301961</nct_id>
  </id_info>
  <brief_title>Multiplex Analysis of Circulating Tumor DNA</brief_title>
  <official_title>The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's 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>
      Lung cancer is the leading cause of cancer-related death in China. This study will explore&#xD;
      the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and&#xD;
      surveillance of lung cancer patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung&#xD;
      cancer and continues to be the leading cause of cancer-related deaths worldwide.Early&#xD;
      diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.&#xD;
&#xD;
      Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in&#xD;
      previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this&#xD;
      study will perform multiplex detection of ctDNA,analysing mutations, methylation and other&#xD;
      biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Carcinoma</condition>
  <condition>Non-small-cell Lung Cancer</condition>
  <condition>Lung Neoplasm</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A series of lung cancer patients plasma before and after surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patient are found nodules in pulmonary and prepare for surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign informed consent and consent to participate in this study;&#xD;
&#xD;
          2. Found small nodules in pulmonary by CT and prepare for surgery;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Malignant tumor history within the past 5 years;&#xD;
&#xD;
          2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;&#xD;
&#xD;
          3. No matching tissue or blood samplesUnqualified blood samples&#xD;
&#xD;
          4. Lesion is pure ground glass opacity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kezhong Chen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kezhong Chen, MD</last_name>
    <phone>（+86）13488752289</phone>
    <email>mdkzchen@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heng Zhao, MD</last_name>
    <phone>（+86）13683139396</phone>
    <email>zhaohengzhaoheng@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kezhong Chen, M.D.</last_name>
      <phone>+8613488752289</phone>
      <email>mdkzchen@163.com</email>
    </contact>
    <investigator>
      <last_name>Jun Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Jun Wang</investigator_full_name>
    <investigator_title>Chief，Thoracic Surgery Service</investigator_title>
  </responsible_party>
  <keyword>Circulating Tumor DNA</keyword>
  <keyword>Early diagnosis</keyword>
  <keyword>Surveillance</keyword>
  <keyword>Methylation</keyword>
  <keyword>Somatic mutation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03301961
org study id: PTHO1701
nct id: NCT03301961
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lung cancer is the leading cause of cancer-related death in China. This study will explore
      the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and
      surveillance of lung cancer patients
Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung
      cancer and continues to be the leading cause of cancer-related deaths worldwide.Early
      diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.

      Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in
      previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this
      study will perform multiplex detection of ctDNA,analysing mutations, methylation and other
      biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.
observational model: Case-Only
time perspective: Prospective
measure: The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
time frame: 12 months
measure: Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer
time frame: 12 months
measure: The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection
time frame: 36 months
measure: Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches
time frame: 36 months
A series of lung cancer patients plasma before and after surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Kezhong Chen, MD
role: Study Director
affiliation: Peking University People's Hospital
last name: Kezhong Chen, MD
phone: （+86）13488752289
email: mdkzchen@163.com
last name: Heng Zhao, MD
phone: （+86）13683139396
email: zhaohengzhaoheng@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Jun Wang
investigator title: Chief，Thoracic Surgery Service
mesh term: Lung Neoplasms