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/NCT05970913</url>
    </required_header>
    <id_info>
      <org_study_id>ECTOP-1017</org_study_id>
      <nct_id>NCT05970913</nct_id>
    </id_info>
    <brief_title>PET-CT Predicting Segement Specific Lymph Nodes Metastasis</brief_title>
    <official_title>The Value of PET-CT in Predicting Segement Specific Lymph Nodes Metastasis in Non Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</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>
        This study is a multicenter prospective clinical study that aims to evaluate the predictive&#xD;
        value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and&#xD;
        differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in&#xD;
        patients with non-small cell lung cancer. During surgery, all patients underwent systematic&#xD;
        mediastinal lymph node dissection. The final pathological results were used to assess the&#xD;
        predictive value of PET-CT for segment-specific lymph node metastasis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Predictive value of PET-CT for segment-specific lymph node metastasis</measure>
      <time_frame>Preoperative</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">280</enrollment>
    <condition>Non Small Cell Lung Cancer</condition>
    <condition>Lymph Node Metastasis</condition>
    <condition>Positron Emission Tomography</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients had non small cell lung cancer received surgery and systematic lymph node&#xD;
          dissection.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from&#xD;
               the primary lesion.&#xD;
  &#xD;
            -  Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.&#xD;
  &#xD;
            -  No enlarged mediastinal lymph nodes observed on preoperative contrast-enhanced CT.&#xD;
  &#xD;
            -  Pathological confirmation of non-small cell lung cancer (NSCLC) either before or&#xD;
               during surgery.&#xD;
  &#xD;
            -  Systematic lymph node dissection performed during surgery.&#xD;
  &#xD;
            -  No prior radiotherapy or chemotherapy for initial treatment.&#xD;
  &#xD;
            -  No history of malignant tumors.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Locally advanced or distant metastasis.&#xD;
  &#xD;
            -  Pleural dissemination observed during surgery.&#xD;
  &#xD;
            -  History of malignant tumors.&#xD;
  &#xD;
            -  Received neoadjuvant therapy.&#xD;
  &#xD;
            -  Systematic lymph node dissection not performed during surgery.&#xD;
  &#xD;
            -  Histopathological examination reveals lung malignancies other than non-small cell lung&#xD;
               cancer (NSCLC).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hang Li</last_name>
      <phone>+862164175590</phone>
      <email>drlihang@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hang Li</last_name>
        <email>drlihang@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Haiquan Chen</investigator_full_name>
      <investigator_title>Chief of the MDT board of thoracic cancer</investigator_title>
    </responsible_party>
    <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>
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Lymphatic 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/NCT05970913
  org study id: ECTOP-1017
  nct id: NCT05970913
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multicenter prospective clinical study that aims to evaluate the predictive
        value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and
        differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in
        patients with non-small cell lung cancer. During surgery, all patients underwent systematic
        mediastinal lymph node dissection. The final pathological results were used to assess the
        predictive value of PET-CT for segment-specific lymph node metastasis.
  observational model: Cohort
  time perspective: Prospective
  measure: Predictive value of PET-CT for segment-specific lymph node metastasis
  time frame: Preoperative
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hang Li
  phone: +862164175590
  email: drlihang@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Haiquan Chen
  investigator title: Chief of the MDT board of thoracic cancer
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Neoplasm Metastasis
  mesh term: Lymphatic Metastasis