<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/NCT03764917</url>
  </required_header>
  <id_info>
    <org_study_id>YS2018-003</org_study_id>
    <nct_id>NCT03764917</nct_id>
  </id_info>
  <brief_title>NGS Combined With RNAseq on Tumor Immune Escape in NSCLC</brief_title>
  <official_title>Study on the Effect of NGS Combined With RNAseq on Tumor Immune Escape in Advanced Non-small Cell Lung Cancer EGFR and ALK Mutant Negative Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pulmonary Hospital, Shanghai, China</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>
      Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR&#xD;
      and ALK mutant negative by NGS combined with RNAseq&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR&#xD;
      and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer&#xD;
      patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and&#xD;
      after disease progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>numbers of immune cells</measure>
    <time_frame>24 months</time_frame>
    <description>detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>numbers of tumor mutations</measure>
    <time_frame>24 months</time_frame>
    <description>detecting numbers of tumor mutations before first-line chemotherapy, after two cycles chemotherapy and after disease progression</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Time</intervention_name>
    <description>Different detecting time</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy&#xD;
        Without EGFR and Alk mutation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        EGFR mutant positive Alk mutant positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yayi He, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Tongji University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 22, 2020</last_update_submitted>
  <last_update_submitted_qc>March 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
    <investigator_full_name>Caicun Zhou</investigator_full_name>
    <investigator_title>Prof. Caicun Zhou</investigator_title>
  </responsible_party>
  <keyword>NGS</keyword>
  <keyword>RNAseq</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/NCT03764917
org study id: YS2018-003
nct id: NCT03764917
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR
      and ALK mutant negative by NGS combined with RNAseq
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR
      and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer
      patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and
      after disease progression.
observational model: Cohort
time perspective: Prospective
measure: numbers of immune cells
time frame: 24 months
description: detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression
measure: numbers of tumor mutations
time frame: 24 months
description: detecting numbers of tumor mutations before first-line chemotherapy, after two cycles chemotherapy and after disease progression
intervention type: Other
intervention name: Time
description: Different detecting time
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yayi He, MD, PHD
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Tongji University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
investigator full name: Caicun Zhou
investigator title: Prof. Caicun Zhou
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided