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/NCT06017271</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-269</org_study_id>
      <nct_id>NCT06017271</nct_id>
    </id_info>
    <brief_title>Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer</brief_title>
    <official_title>Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong 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>
        The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT).&#xD;
        Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory&#xD;
        cytokines and adipokines, participating in the formation of local inflammation, promoting the&#xD;
        formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients&#xD;
        with lung cancer have increased inflammatory response and are more prone to suffer&#xD;
        thrombosis. However, in lung cancer patients, the clinical correlation between EAT and&#xD;
        pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor&#xD;
        prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in&#xD;
        pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density,&#xD;
        as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer&#xD;
        patients, half with pulmonary embolism and half without. The incidence of adverse prognosis&#xD;
        and related factors were followed up by telephone.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>EAT volume</measure>
      <time_frame>May, 20, 2023</time_frame>
      <description>volume of epicardial adipose tissue (EAT), Cm3</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EAT density</measure>
      <time_frame>May, 20, 2023</time_frame>
      <description>density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Pulmonary Embolism</condition>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>PE group</arm_group_label>
      <description>The CTPA diagnosis suggest pulmonary embolism</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>The CTPA diagnosis did not suggest pulmonary embolism</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CTPA (computed tomography pulmonary angiography)</intervention_name>
      <description>The CTPA diagnosis suggest or did not suggest pulmonary embolism.</description>
      <arm_group_label>PE group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study was conducted on patients with a confirmed diagnosis of Lung Cancer who were&#xD;
          admitted to the First Affiliated Hospital of Xi'an Jiaotong University from 1 January 2012&#xD;
          to 31 December 2021. Patients who did not meet any of the inclusion criteria or met any of&#xD;
          the exclusion criteria were excluded. The subjects were divided into PE group and control&#xD;
          group according to the results of CTPA examination, and the patients in the two groups were&#xD;
          matched by gender and age 1:1 tendency score.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The pathological diagnosis was lung cancer&#xD;
  &#xD;
            -  Pulmonary artery was evaluated by CTA during hospitalization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with incomplete clinical data&#xD;
  &#xD;
            -  Patients with no follow-up data&#xD;
  &#xD;
            -  Patients with a history of PE before diagnosis of lung cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yang Yan</last_name>
      <role>Study Director</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Haichen Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Yan</last_name>
      <phone>13259882601</phone>
      <email>yangyan3@xjtu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Haichen Wang</last_name>
      <phone>18991232986</phone>
      <email>whccvsdc@xjtufh.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Affiliated Hospital of Xian Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>Pulmonary Embolism</mesh_term>
      <mesh_term>Embolism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06017271
  org study id: XJTU1AF2023LSK-269
  nct id: NCT06017271
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT).
        Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory
        cytokines and adipokines, participating in the formation of local inflammation, promoting the
        formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients
        with lung cancer have increased inflammatory response and are more prone to suffer
        thrombosis. However, in lung cancer patients, the clinical correlation between EAT and
        pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor
        prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in
        pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density,
        as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer
        patients, half with pulmonary embolism and half without. The incidence of adverse prognosis
        and related factors were followed up by telephone.
  observational model: Cohort
  time perspective: Retrospective
  measure: EAT volume
  time frame: May, 20, 2023
  description: volume of epicardial adipose tissue (EAT), Cm3
  measure: EAT density
  time frame: May, 20, 2023
  description: density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)
  arm group label: PE group
  description: The CTPA diagnosis suggest pulmonary embolism
  arm group label: control group
  description: The CTPA diagnosis did not suggest pulmonary embolism
  intervention type: Diagnostic Test
  intervention name: CTPA (computed tomography pulmonary angiography)
  description: The CTPA diagnosis suggest or did not suggest pulmonary embolism.
  arm group label: PE group
  arm group label: control group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Yang Yan
  role: Study Director
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Haichen Wang
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Yang Yan
  phone: 13259882601
  email: yangyan3@xjtu.edu.cn
  last name: Haichen Wang
  phone: 18991232986
  email: whccvsdc@xjtufh.edu.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Pulmonary Embolism
  mesh term: Embolism
  sharing ipd: Undecided