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/NCT05991193</url>
    </required_header>
    <id_info>
      <org_study_id>FORCE RWS</org_study_id>
      <nct_id>NCT05991193</nct_id>
    </id_info>
    <brief_title>A Non-interventional Study With Central Nervous System Metastatic EGFR Mutation Positive NSCLC</brief_title>
    <official_title>A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Province Tumor Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hunan Province Tumor Hospital</source>
    <oversight_info>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a descriptive observational study, in which data are collected in an epidemiological&#xD;
        fashion and prospective. This study does not intend to intervene the current medical practice&#xD;
        of the recruited patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</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>Progression-free survival</measure>
      <time_frame>2 years</time_frame>
      <description>Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Central nervous system (CNS) progression-free survival</measure>
      <time_frame>2 years</time_frame>
      <description>CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</measure>
      <time_frame>2 years</time_frame>
      <description>Defined as the number (%) of patients with response of Complete Response or Partial Response</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>NSCLC</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        needle biopsy for samples with DNA&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must be ≥18 years.&#xD;
  &#xD;
            -  Provision of fully informed consent prior to any study specific procedures.&#xD;
  &#xD;
            -  Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.&#xD;
               The mutations above may exist alone or together.&#xD;
  &#xD;
            -  Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).&#xD;
  &#xD;
            -  According to the RECIST 1.1 standard, the patient must have at least one measurable&#xD;
               lesion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#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>Yongchang Zhang, MD</last_name>
      <phone>+8613873123436</phone>
      <email>zhangyongchang@csu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nong Yang, MD</last_name>
      <phone>+8613873123436</phone>
      <email>yangnong0217@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hunan Cancer hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
      <investigator_full_name>Yongchang Zhang</investigator_full_name>
      <investigator_title>Professor, Deputy Director of Thoracic Oncology Department</investigator_title>
    </responsible_party>
    <!-- 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/NCT05991193
  org study id: FORCE RWS
  nct id: NCT05991193
  lead sponsor: 
  is fda regulated device: No
  This is a descriptive observational study, in which data are collected in an epidemiological
        fashion and prospective. This study does not intend to intervene the current medical practice
        of the recruited patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Progression-free survival
  time frame: 2 years
  description: Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
  measure: Central nervous system (CNS) progression-free survival
  time frame: 2 years
  description: CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.
  measure: Objective Response Rate
  time frame: 2 years
  description: Defined as the number (%) of patients with response of Complete Response or Partial Response
  needle biopsy for samples with DNA
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yongchang Zhang, MD
  phone: +8613873123436
  email: zhangyongchang@csu.edu.cn
  last name: Nong Yang, MD
  phone: +8613873123436
  email: yangnong0217@163.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hunan Province Tumor Hospital
  investigator full name: Yongchang Zhang
  investigator title: Professor, Deputy Director of Thoracic Oncology Department