xml: <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/NCT05997719</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-287-01</org_study_id>
      <nct_id>NCT05997719</nct_id>
    </id_info>
    <brief_title>Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC</brief_title>
    <official_title>Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen 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>
        To investigate genomic architecture, cancer evolution and their relationship with clinical&#xD;
        outcomes in EGFR-mutant NSCLC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC.&#xD;
        EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early&#xD;
        diversification, genome instability, low background mutation rates. But despite its high ITH,&#xD;
        EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even&#xD;
        without the application of targeted therapies, indicating that EGFR mutations may have&#xD;
        distinct impacts on cancer evolution. This study intends to investigate the genomic&#xD;
        architecture, cancer evolution trajectories and their relationship with clinical outcomes in&#xD;
        EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population&#xD;
        that could potentially guide therapeutic decisions and improved clinical outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 8, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Intratumor heterogeneity (ITH)</measure>
      <time_frame>5 years</time_frame>
      <description>Intratumor heterogeneity in terms of genomic architecture, transcriptomic profiles and clonal composition; Investigate the relationship between ITH, clinical features and clinical outcomes in EGFR-mutant NSCLC</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical utility of ctDNA in EGFR-mutant NSCLC</measure>
      <time_frame>5 years</time_frame>
      <description>Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC</description>
    </secondary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Non-small Cell Lung Cancer</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        tissue, blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Histologically or cytologically confirmed EGFR-mutant NSCLC&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 18 years or older&#xD;
  &#xD;
            2. Histologically or cytologically confirmed non-small-cell lung cancer&#xD;
  &#xD;
            3. ECOG PS=0-2&#xD;
  &#xD;
            4. EGFR mutations confirmed by tissue or peripheral blood&#xD;
  &#xD;
            5. Can provide tumor tissue samples (fresh or archived)&#xD;
  &#xD;
            6. The subject should have good compliance, who would participate in the research&#xD;
               voluntarily, and sign the informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of other malignancies within 5 years (excluding basal cell carcinoma of the&#xD;
               skin or other carcinoma in situ that has been resected).&#xD;
  &#xD;
            2. Unable to provide sufficient tumor tissue for analysis.&#xD;
  &#xD;
            3. Subjects with active, unstable systemic diseases, such as active infection,&#xD;
               uncontrolled hypertension, heart failure (NYHA class &gt;= II), unstable angina pectoris,&#xD;
               acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases,&#xD;
               HIV infection.&#xD;
  &#xD;
            4. Subjects who are deemed unable to comply with the study requirements or complete the&#xD;
               study.&#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_contact>
      <last_name>Shen Zhao, MD.</last_name>
      <phone>86 20 87343366</phone>
      <email>zhaoshen@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guanzhou</city>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Zhang, MD.</last_name>
        <phone>86 20 87343366</phone>
        <email>zhangli@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Li Zhang, MD</investigator_full_name>
      <investigator_title>Chief of Medical Oncology Department</investigator_title>
    </responsible_party>
    <keyword>EGFR mutation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997719
  org study id: B2023-287-01
  nct id: NCT05997719
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To investigate genomic architecture, cancer evolution and their relationship with clinical
        outcomes in EGFR-mutant NSCLC.
  EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC.
        EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early
        diversification, genome instability, low background mutation rates. But despite its high ITH,
        EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even
        without the application of targeted therapies, indicating that EGFR mutations may have
        distinct impacts on cancer evolution. This study intends to investigate the genomic
        architecture, cancer evolution trajectories and their relationship with clinical outcomes in
        EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population
        that could potentially guide therapeutic decisions and improved clinical outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Intratumor heterogeneity (ITH)
  time frame: 5 years
  description: Intratumor heterogeneity in terms of genomic architecture, transcriptomic profiles and clonal composition; Investigate the relationship between ITH, clinical features and clinical outcomes in EGFR-mutant NSCLC
  measure: Clinical utility of ctDNA in EGFR-mutant NSCLC
  time frame: 5 years
  description: Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC
  tissue, blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shen Zhao, MD.
  phone: 86 20 87343366
  email: zhaoshen@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Li Zhang, MD
  investigator title: Chief of Medical Oncology Department
  mesh term: Carcinoma, Non-Small-Cell Lung