<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/NCT02185495</url>
  </required_header>
  <id_info>
    <org_study_id>13411950100</org_study_id>
    <nct_id>NCT02185495</nct_id>
  </id_info>
  <brief_title>Screening for Early Lung Cancer in Shanghai, China</brief_title>
  <official_title>Screening and Diagnosing for Early Lung Cancer in Shanghai Communities With Imaging Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Public Health Clinical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Changzheng Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Imaging procedures including chest X-ray and low-dose computed tomography may be effective in&#xD;
      lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined&#xD;
      with computer aided detection （CAD) is more effective than LDCT in screening of early lung&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided&#xD;
      low-dose computed tomography and low-dose computed tomography in lung cancer screening for&#xD;
      community individuals in Shanghai, China. Thus, an imaging protocol which can detect early&#xD;
      lung cancer in asymptomatic high risk patients will be proposed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer</measure>
    <time_frame>24months</time_frame>
    <description>A questionaire will be recorded for each subject, including demographics, smoking history and disease history, etc. If a pulmonary nodule was found, the location, shape, size, margin and density will be recorded.&#xD;
A subject with a suspected malignant nodule, which was detected either by a radiologist or computed-aiding detection software, will refer to a physician for further management.&#xD;
Finally, the sensitivities of radiologist or software detection will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared</measure>
    <time_frame>24months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nodule detection rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>High-risk individuals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using &quot;Observer nodule detection&quot; and &quot; Computer-aided nodule detection&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Observer nodule detection</intervention_name>
    <description>Radiologists will detect the nodules.</description>
    <arm_group_label>High-risk individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer-aided nodule detection</intervention_name>
    <description>Computed-aided detection (CAD) software will be used to detect the nodules.</description>
    <arm_group_label>High-risk individuals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former&#xD;
             smoker, have quit within 15 years&#xD;
&#xD;
          -  Age 50 or older ,20 or more pack-year history of smoking, and one additional risk&#xD;
             factor (occupational exposure, residential radon exposure, cancer history, family&#xD;
             history of lung cancer, history of lung disease)&#xD;
&#xD;
          -  Age 35 and one additional risk factor&#xD;
&#xD;
          -  Ability to accept LDCT examination and sign informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing,&#xD;
             chest pain, weight loss, blood-stained sputum）&#xD;
&#xD;
          -  Individuals with acute pulmonary abnormalities or those in poor health conditions or&#xD;
             those have metallic implants or devices in the chest or back will be excluded due to&#xD;
             the potential impact on the results as well as difficulty of acquiring the images.&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiyuan Liu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Radiology Department of Shanghai Changzheng Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiyuan Liu, MD</last_name>
    <phone>+86-13761304518</phone>
    <email>cjr.liushiyuan@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiyuan Liu, Prof.MD.PhD.</last_name>
      <phone>+86-13761304518</phone>
      <email>cjr.liushiyuan@vip.163.com</email>
    </contact>
    <investigator>
      <last_name>ShiYuan Liu, Prof.MD.PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ying Zhou, MD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Liu ShiYuan</investigator_full_name>
    <investigator_title>Shanghai Changzheng Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02185495
org study id: 13411950100
nct id: NCT02185495
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Imaging procedures including chest X-ray and low-dose computed tomography may be effective in
      lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined
      with computer aided detection （CAD) is more effective than LDCT in screening of early lung
      cancer.
The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided
      low-dose computed tomography and low-dose computed tomography in lung cancer screening for
      community individuals in Shanghai, China. Thus, an imaging protocol which can detect early
      lung cancer in asymptomatic high risk patients will be proposed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
time frame: 24months
description: A questionaire will be recorded for each subject, including demographics, smoking history and disease history, etc. If a pulmonary nodule was found, the location, shape, size, margin and density will be recorded.
A subject with a suspected malignant nodule, which was detected either by a radiologist or computed-aiding detection software, will refer to a physician for further management.
Finally, the sensitivities of radiologist or software detection will be calculated.
measure: The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared
time frame: 24months
measure: Nodule detection rate
time frame: 6 months
arm group label: High-risk individuals
arm group type: Experimental
description: The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using "Observer nodule detection" and " Computer-aided nodule detection".
intervention type: Behavioral
intervention name: Observer nodule detection
description: Radiologists will detect the nodules.
arm group label: High-risk individuals
intervention type: Device
intervention name: Computer-aided nodule detection
description: Computed-aided detection (CAD) software will be used to detect the nodules.
arm group label: High-risk individuals
criteria: 
gender: All
minimum age: 35 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shiyuan Liu, MD
role: Study Director
affiliation: Radiology Department of Shanghai Changzheng Hospital
last name: Shiyuan Liu, MD
phone: +86-13761304518
email: cjr.liushiyuan@vip.163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Liu ShiYuan
investigator title: Shanghai Changzheng Hospital
mesh term: Lung Neoplasms