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/NCT06026735</url>
    </required_header>
    <id_info>
      <org_study_id>202209032RINB</org_study_id>
      <nct_id>NCT06026735</nct_id>
    </id_info>
    <brief_title>Non-small Cell Lung Cancer With Central Nervous System Metastasis</brief_title>
    <official_title>Comprehensive Profiling of Promising Biomarkers in Exosomes From Non-small Cell Lung Cancer With Central Nervous System Metastasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer&#xD;
        patients with central nervous system metastasis, blood was obtained from veins, and&#xD;
        metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or&#xD;
        meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned&#xD;
        samples, and compare and analyze the clinical data of the patients, so as to explore whether&#xD;
        the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor&#xD;
        tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 13, 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>predict lung cancer metastasis and Bioindicators of treatment effect</measure>
      <time_frame>follow 3 years</time_frame>
      <description>Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Lung Cancer With Central Nervous System Metastasis</condition>
    <arm_group>
      <arm_group_label>lung cancer with brain metastasis</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>lung cancer with leptomeningeal metastasis</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>lung cancer with brain /leptomeningeal metastasis</intervention_name>
      <description>Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.</description>
      <arm_group_label>lung cancer with brain metastasis</arm_group_label>
      <arm_group_label>lung cancer with leptomeningeal metastasis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Non-small cell lung cancer patients with brain metastases or meningeal metastases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - A. Non-small cell lung cancer patients diagnosed with brain metastases or meningeal&#xD;
          metastases on brain computed tomography (CT) or magnetic resonance (MRI) images.&#xD;
  &#xD;
          B. Patients with non-small cell lung cancer who are about to undergo surgical brain&#xD;
          surgery, such as brain tumor resection, lumbar abdominal drainage, Euclidean storage, or&#xD;
          ventriculoperitoneal drainage.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - A. Non-small cell lung cancer patients without brain metastases or meningeal metastases.&#xD;
  &#xD;
          B. Physical condition does not allow surgical removal of the tumor.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>ABEL HUANG, MD</last_name>
      <phone>+8860223123456</phone>
      <phone_ext>265913</phone_ext>
      <email>how.how0622@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>ABEL HUANG</last_name>
      <phone>+8860223123456</phone>
      <phone_ext>265913</phone_ext>
      <email>how.how0622@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ABEL HUANG</last_name>
        <phone>023123456</phone>
        <phone_ext>265913</phone_ext>
        <email>how.how0622@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>October 25, 2022</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Neoplasm Metastasis</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/NCT06026735
  org study id: 202209032RINB
  nct id: NCT06026735
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer
        patients with central nervous system metastasis, blood was obtained from veins, and
        metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or
        meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned
        samples, and compare and analyze the clinical data of the patients, so as to explore whether
        the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor
        tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.
  observational model: Case-Only
  time perspective: Prospective
  measure: predict lung cancer metastasis and Bioindicators of treatment effect
  time frame: follow 3 years
  description: Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.
  arm group label: lung cancer with brain metastasis
  arm group label: lung cancer with leptomeningeal metastasis
  intervention type: Other
  intervention name: lung cancer with brain /leptomeningeal metastasis
  description: Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.
  arm group label: lung cancer with brain metastasis
  arm group label: lung cancer with leptomeningeal metastasis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: ABEL HUANG, MD
  phone: +8860223123456
  phone ext: 265913
  email: how.how0622@gmail.com
  last name: ABEL HUANG
  phone: +8860223123456
  phone ext: 265913
  email: how.how0622@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Neoplasm Metastasis