<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/NCT04419207</url>
  </required_header>
  <id_info>
    <org_study_id>2019PHB095-01</org_study_id>
    <nct_id>NCT04419207</nct_id>
  </id_info>
  <brief_title>Detecting Lung Cancer Based on Exhaled Breath</brief_title>
  <official_title>Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Haidian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aerospace 731 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Breatha Biological Technology Co., Ltd, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangsu Cancer Institute &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's Hospital</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>
      Early detection is critical to improve the overall survival of lung cancer. Endogenous&#xD;
      volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On&#xD;
      the other hand, cancer cells have different metabolism patterns compared with normal cells.&#xD;
      Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a&#xD;
      promising approach for lung cancer detection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic&#xD;
      pathways. VOCs can be transported to the alveoli through the blood circulation and expelled&#xD;
      by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood&#xD;
      exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled&#xD;
      breath has the advantages of being completely non-invasive and easy to collect, and has been&#xD;
      considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many&#xD;
      clinical studies have found that VOCs in exhaled breath are closely related to disease&#xD;
      status. Specific VOCs alterations have been identified in many tumors, especially lung&#xD;
      cancer.&#xD;
&#xD;
      In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung&#xD;
      cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry&#xD;
      data and support vector machine will be initially established and validated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic sensitivity of exhaled breath</measure>
    <time_frame>2 year</time_frame>
    <description>Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic specificity of exhaled breath</measure>
    <time_frame>2 year</time_frame>
    <description>Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive predictive value of exhaled breath</measure>
    <time_frame>2 year</time_frame>
    <description>Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative predictive value of exhaled breath</measure>
    <time_frame>2 year</time_frame>
    <description>Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy of exhaled breath</measure>
    <time_frame>2 year</time_frame>
    <description>Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2236</enrollment>
  <condition>Carcinoma</condition>
  <condition>Lung Cancer</condition>
  <condition>NSCLC</condition>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with Surbery</arm_group_label>
    <description>Patients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Adult participants (&gt;18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath test</intervention_name>
    <description>Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Patients with Surbery</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Exhaled breath samples will be collected with air bags.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible inpatients will be recruited from Department of Thoracic Surgery, Peking&#xD;
        University People's Hospital and Beijing Haidian Hospital.&#xD;
&#xD;
        For healthy controls, eligible participants will be recruited from those who receive&#xD;
        planned annual physical examination at Aerospace 731 Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for inpatient :&#xD;
&#xD;
          -  pulmonary nodules in competed tomography images&#xD;
&#xD;
          -  plan to receive thoracic surgery&#xD;
&#xD;
        Inclusion Criteria for controls :&#xD;
&#xD;
          -  have planned physical examination every year&#xD;
&#xD;
          -  plan to receive low-dose computed tomography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of malignant tumors.&#xD;
&#xD;
          -  receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy&#xD;
             before surgery&#xD;
&#xD;
          -  with infections or liver disease&#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_official>
    <last_name>Mantang Qiu, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital Thoracic Surgery Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zuli Zhou, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>zhouzuli</investigator_full_name>
    <investigator_title>M.D.，Department of Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>volatile organic compounds</keyword>
  <keyword>exhaled breath</keyword>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04419207
org study id: 2019PHB095-01
nct id: NCT04419207
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Early detection is critical to improve the overall survival of lung cancer. Endogenous
      volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On
      the other hand, cancer cells have different metabolism patterns compared with normal cells.
      Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a
      promising approach for lung cancer detection.
Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic
      pathways. VOCs can be transported to the alveoli through the blood circulation and expelled
      by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood
      exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled
      breath has the advantages of being completely non-invasive and easy to collect, and has been
      considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many
      clinical studies have found that VOCs in exhaled breath are closely related to disease
      status. Specific VOCs alterations have been identified in many tumors, especially lung
      cancer.

      In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung
      cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry
      data and support vector machine will be initially established and validated.
observational model: Case-Control
time perspective: Prospective
measure: Diagnostic sensitivity of exhaled breath
time frame: 2 year
description: Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated
measure: Diagnostic specificity of exhaled breath
time frame: 2 year
description: Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated
measure: Positive predictive value of exhaled breath
time frame: 2 year
description: Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated
measure: Negative predictive value of exhaled breath
time frame: 2 year
description: Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated
measure: Diagnostic accuracy of exhaled breath
time frame: 2 year
description: Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated
arm group label: Patients with Surbery
description: Patients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.
arm group label: Healthy Controls
description: Adult participants (>18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.
intervention type: Diagnostic Test
intervention name: Breath test
description: Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).
arm group label: Healthy Controls
arm group label: Patients with Surbery
Exhaled breath samples will be collected with air bags.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mantang Qiu, M.D
role: Study Chair
affiliation: Peking University People's Hospital Thoracic Surgery Department
last name: Zuli Zhou, M.D
role: Principal Investigator
affiliation: Peking University People's Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: zhouzuli
investigator title: M.D.，Department of Thoracic Surgery
mesh term: Lung Neoplasms
sharing ipd: No