<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/NCT03244904</url>
  </required_header>
  <id_info>
    <org_study_id>CSWOG01</org_study_id>
    <nct_id>NCT03244904</nct_id>
  </id_info>
  <brief_title>Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment</brief_title>
  <official_title>a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Cancer Hospital</source>
  <brief_summary>
    <textblock>
      Participants will be consented into the study after they are found to meet the study&#xD;
      inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the&#xD;
      participant to give NGS(Next-generation Sequencing).One is according to the germline mutation&#xD;
      data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the&#xD;
      extensive consistency detection of blood and tissues in patients with SCLC gene mutation&#xD;
      information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in&#xD;
      patients with SCLC during treatment, by changing the types of mutations / abundance (for&#xD;
      example: the clonal evolution of typical samples analysis) and change of tumor load, ,&#xD;
      investigating the patients treatment effect , for the significant change of mutations, to&#xD;
      study whether it can be used as molecular marker; four is to analyze of the molecular typing&#xD;
      of SCLC, according to the clinical and pathological features of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>susceptibility gene site of small cell lung cancer</measure>
    <time_frame>01.11.2017-31.05.2018</time_frame>
    <description>searching susceptibility gene site of small cell lung cancer according to germline mutation data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>consistency of ctDNA and tDNA sequencing results in patients with SCLC</measure>
    <time_frame>01.11.2017-31.05.2018</time_frame>
    <description>explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC</description>
  </secondary_outcome>
  <other_outcome>
    <measure>sensitive molecular markers for treating</measure>
    <time_frame>01.11.2017-31.05.2018</time_frame>
    <description>during treatment of blood ctDNA for dynamic monitoring, through the mutation type/abundance changes (for example, a typical sample of clonal evolution analysis) and tumor mutation load change, studying whether significant changes of mutations can be used as molecular markers of SCLC</description>
  </other_outcome>
  <other_outcome>
    <measure>molecular classification of SCLC</measure>
    <time_frame>01.11.2017-31.05.2018</time_frame>
    <description>according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types</description>
  </other_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>SCLC</condition>
  <eligibility>
    <study_pop>
      <textblock>
        SCLC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must understand the rigors of the study and provide written informed consent&#xD;
             and HIPAA authorization prior to initiation of any study procedures&#xD;
&#xD;
          -  Life expectancy &gt; 10 months&#xD;
&#xD;
          -  Karnofsky Performance Status ≥ 70&#xD;
&#xD;
          -  Diagnosis of histological or cytologically confirmed SCLC,&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Good medical candidate for and willing to undergo a biopsy or surgical procedure to&#xD;
             obtain tissue, which may or may not be part of the patient's routine care for their&#xD;
             malignancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor compliance, reluctant to undergo research medication, or follow-up.&#xD;
&#xD;
          -  Tumor inaccessible for biopsy&#xD;
&#xD;
          -  It is currently included in clinical trials of other drugs, or at the same time, into&#xD;
             other medical studies that are considered incompatible with the study.&#xD;
&#xD;
          -  It has a history of other cancers, unless the cancer is completely relieved and has&#xD;
             not been treated for more than 3 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gen Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CSWOG</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gen Lin, MD,PhD</last_name>
    <phone>008613313786157</phone>
    <email>lingen197505@163.com</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 5, 2017</last_update_submitted>
  <last_update_submitted_qc>August 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NGS,SCLC, ctDNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Small Cell Lung Carcinoma</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/NCT03244904
org study id: CSWOG01
nct id: NCT03244904
lead sponsor: 
Participants will be consented into the study after they are found to meet the study
      inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the
      participant to give NGS(Next-generation Sequencing).One is according to the germline mutation
      data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the
      extensive consistency detection of blood and tissues in patients with SCLC gene mutation
      information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in
      patients with SCLC during treatment, by changing the types of mutations / abundance (for
      example: the clonal evolution of typical samples analysis) and change of tumor load, ,
      investigating the patients treatment effect , for the significant change of mutations, to
      study whether it can be used as molecular marker; four is to analyze of the molecular typing
      of SCLC, according to the clinical and pathological features of patients.
observational model: Cohort
time perspective: Prospective
measure: susceptibility gene site of small cell lung cancer
time frame: 01.11.2017-31.05.2018
description: searching susceptibility gene site of small cell lung cancer according to germline mutation data
measure: consistency of ctDNA and tDNA sequencing results in patients with SCLC
time frame: 01.11.2017-31.05.2018
description: explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC
measure: sensitive molecular markers for treating
time frame: 01.11.2017-31.05.2018
description: during treatment of blood ctDNA for dynamic monitoring, through the mutation type/abundance changes (for example, a typical sample of clonal evolution analysis) and tumor mutation load change, studying whether significant changes of mutations can be used as molecular markers of SCLC
measure: molecular classification of SCLC
time frame: 01.11.2017-31.05.2018
description: according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Gen Lin, MD,PhD
role: Principal Investigator
affiliation: CSWOG
last name: Gen Lin, MD,PhD
phone: 008613313786157
email: lingen197505@163.com
responsible party type: Sponsor
mesh term: Small Cell Lung Carcinoma
sharing ipd: Undecided