<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/NCT02988141</url>
  </required_header>
  <id_info>
    <org_study_id>CCTC1601</org_study_id>
    <nct_id>NCT02988141</nct_id>
  </id_info>
  <brief_title>EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC</brief_title>
  <acronym>PRECENT</acronym>
  <official_title>A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianxing He</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese&#xD;
      Patients with Advanced EGFRm+ NSCLC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with EGFR mutation and presented secondary resistance to prior first-generation&#xD;
      EGFR-TKI should have received biopsy of at least on progressed lesions and are able to&#xD;
      provide tissues for pathological examination and NGS testing.All enrolled patients will be&#xD;
      followed up to clinical outcome (treatments, tumor response, survival, etc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The biomarker profile of EGFR-TKI resistance</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The concordance, sensitivity and specificity in paired blood and tissue samples</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      ctDNA in blood and tissues&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        EGFR mutation positive patients with paired tissue and blood samples&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent prior to any study specific procedures.&#xD;
&#xD;
          -  Male or female patients aged 18 years and older.&#xD;
&#xD;
          -  Histological confirmation of stage IIIB/IV NSCLC.&#xD;
&#xD;
          -  Documented EGFR mutation positive .&#xD;
&#xD;
          -  WHO Performance Status 0, 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other significant clinical disorder or laboratory finding that made it undesirable&#xD;
             for the patient to participate in the study.&#xD;
&#xD;
          -  Previous (within 6 months) or current treatment with AZD9291.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian Xing HE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian Xing HE, MD</last_name>
    <phone>86-20-83062338</phone>
    <phone_ext>0</phone_ext>
    <email>yxy701@126.com</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Jianxing He</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02988141
org study id: CCTC1601
nct id: NCT02988141
lead sponsor: 
collaborator: 
has dmc: No
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese
      Patients with Advanced EGFRm+ NSCLC
Patients with EGFR mutation and presented secondary resistance to prior first-generation
      EGFR-TKI should have received biopsy of at least on progressed lesions and are able to
      provide tissues for pathological examination and NGS testing.All enrolled patients will be
      followed up to clinical outcome (treatments, tumor response, survival, etc).
observational model: Other
time perspective: Prospective
measure: The biomarker profile of EGFR-TKI resistance
time frame: Baseline
measure: The concordance, sensitivity and specificity in paired blood and tissue samples
time frame: Baseline
ctDNA in blood and tissues
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian Xing HE, MD
role: Principal Investigator
affiliation: China
last name: Jian Xing HE, MD
phone: 86-20-83062338
phone ext: 0
email: yxy701@126.com
responsible party type: Sponsor-Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Jianxing He
investigator title: Principle Investigator
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No