<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/NCT03805256</url>
  </required_header>
  <id_info>
    <org_study_id>12345</org_study_id>
    <nct_id>NCT03805256</nct_id>
  </id_info>
  <brief_title>Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer</brief_title>
  <official_title>Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Soochow University</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>
      Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of&#xD;
      the cancer tissue. All subjects in the control group were negative for ctDNA mutations。&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The potential value of ctDNA in the diagnosis of NSCLC</measure>
    <time_frame>Half a year</time_frame>
    <description>The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The target population comprises all adult patients aged 18 years and older who present with&#xD;
        pulmonary nodules.The study sample will include 60 subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection&#xD;
        were able to enter the study -&#xD;
&#xD;
        Exclusion Criteria:Patients who received any invasive examination or treatment prior to&#xD;
        resection or had a history of malignancy; patients who do not attend follow up after&#xD;
        surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung&#xD;
        cancer in pathology。&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianping Gong, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Second Affiliated Hospital of Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianping chief physician, Doctor</last_name>
    <phone>13701415049</phone>
    <email>gongjianpingsz@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mengqin Xu, Master</last_name>
    <phone>18306202242</phone>
    <email>xumengqin77@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jianping Gong</name>
      <address>
        <city>Suzhou</city>
        <state>Jiang Su</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianping Gong, Doctor</last_name>
      <phone>051267783834</phone>
      <email>gongjianpingsz@162.com</email>
    </contact>
    <contact_backup>
      <last_name>Mengqin Xu, Master</last_name>
      <phone>18306202242</phone>
      <email>xumengqin77@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03805256
org study id: 12345
nct id: NCT03805256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of
      the cancer tissue. All subjects in the control group were negative for ctDNA mutations。
observational model: Case-Control
time perspective: Prospective
measure: The potential value of ctDNA in the diagnosis of NSCLC
time frame: Half a year
description: The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jianping Gong, Doctor
role: Study Director
affiliation: Second Affiliated Hospital of Soochow University
last name: Jianping chief physician, Doctor
phone: 13701415049
email: gongjianpingsz@126.com
last name: Mengqin Xu, Master
phone: 18306202242
email: xumengqin77@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor