<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/NCT01663155</url>
  </required_header>
  <id_info>
    <org_study_id>07-455</org_study_id>
    <secondary_id>State of Ohio grant</secondary_id>
    <secondary_id>06-055</secondary_id>
    <nct_id>NCT01663155</nct_id>
  </id_info>
  <brief_title>Chest Imaging, Breath, and Biomarkers in a Screening Trial</brief_title>
  <official_title>A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators would like to see if lung cancer screening with chest x-rays,computer aided&#xD;
      detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more&#xD;
      responsive to treatment. The investigators would also like to see if early detection will&#xD;
      reduce the incidence of symptomatic advanced lung cancer compared to no screening in former&#xD;
      and current smokers with or without a family history of lung cancer who are 40-75 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fight against lung cancer is waged on three major fronts: prevention, detection and&#xD;
      treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT&#xD;
      scan can detect disease earlier when treatment is more effective. If we improve the detection&#xD;
      of disease, we will see if screening reduces the incidence of symptomatic advanced lung&#xD;
      cancer relative to no screening in people at high risk to develop lung cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>The sensitivities of chest x-ray with CAD and chest CT</measure>
    <time_frame>One year after scan</time_frame>
    <description>The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-specific mortality between screening with chest x-ray and CAD versus no screening</measure>
    <time_frame>One year after scan</time_frame>
    <description>Mortality rate in screening x-ray vs CAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality rate between screening with chest x-ray and CAD versus no screening</measure>
    <time_frame>One year after scan</time_frame>
    <description>All cause mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls</measure>
    <time_frame>One year after scan</time_frame>
    <description>Time between randomization and symptom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population</measure>
    <time_frame>One year after scan</time_frame>
    <description>Cancer detection rate between chest x-ray and CAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quality of life between screening with chest x-ray and CAD versus no screening.</measure>
    <time_frame>One year after scan</time_frame>
    <description>Quality of life between the chest x-ray group and the CAD group</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1424</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>all enrolled subjects</arm_group_label>
    <description>Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>chest x-ray with or without CAD, lose dose CT scan</intervention_name>
    <description>PA view, low dose CT scan</description>
    <arm_group_label>all enrolled subjects</arm_group_label>
    <other_name>CAD</other_name>
    <other_name>computer aided detection</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for&#xD;
      plasma and buffy coat retrieval&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care physicians or any other physician may refer potential candidates.&#xD;
        Additionally, subjects may see marketing materials and contact the research team directly.&#xD;
        There is no restriction to the area of residence of subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 40-75 years&#xD;
&#xD;
          -  If ages 40-59, then one of the following criteria needs to be met:&#xD;
&#xD;
               -  Current or ex-smoker with &gt;25 pack years and a family history of lung&#xD;
                  cancer(parent or sibling) OR&#xD;
&#xD;
               -  current or ex-smoker with &gt; 25 pack years and COPD OR&#xD;
&#xD;
               -  current or ex-smoker with a &gt; 35 pack year history&#xD;
&#xD;
          -  If ages 60-75, then one of the following additional criteria needs to be met:&#xD;
&#xD;
               -  Current or ex-smoker with &gt;25 pack years and a family history of lung cancer&#xD;
                  (parent or sibling) OR&#xD;
&#xD;
               -  Current or ex-smoker with &gt;25 pack years and COPD OR&#xD;
&#xD;
               -  Current or ex-smoker with a &gt;30 pack year history&#xD;
&#xD;
          -  Subject is able to return to Cleveland Clinic for annual follow-up screening&#xD;
&#xD;
          -  Subject is willing to sign a medical release form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current health requires oxygen&#xD;
&#xD;
          -  Have had a chest x-ray or CT of the chest within the last 6 months&#xD;
&#xD;
          -  Previous pneumonectomy&#xD;
&#xD;
          -  Lobectomy of the lung within the last 5 years&#xD;
&#xD;
          -  Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer,&#xD;
             carcinoma in situ of the cervix and localized prostate cancer&#xD;
&#xD;
          -  A medical condition that would prevent treatment for lung cancer&#xD;
&#xD;
          -  Within the last 6 weeks, one of the following has occured:&#xD;
&#xD;
               -  A new cough or chronic cough that has gotten worse&#xD;
&#xD;
               -  Either new shortness of breath, or any worsening of shortness of breath&#xD;
&#xD;
               -  A cough producing blood&#xD;
&#xD;
               -  Constant chest pain&#xD;
&#xD;
               -  Respiratory infection, pneumonia, or cold&#xD;
&#xD;
               -  Unintentional and unexplained weight loss greater than 5% of total body weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Micheal Phillips, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moulay Meziane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chair of Thoracic Imaging</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 10, 2008</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>May 17, 2017</last_update_submitted>
  <last_update_submitted_qc>May 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Moulay Meziane, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>chest x-ray</keyword>
  <keyword>CT scan</keyword>
  <keyword>computer aided detection (CAD)</keyword>
  <keyword>screening</keyword>
  <keyword>smokers</keyword>
  <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/NCT01663155
org study id: 07-455
secondary id: State of Ohio grant
secondary id: 06-055
nct id: NCT01663155
lead sponsor: 
has dmc: Yes
The investigators would like to see if lung cancer screening with chest x-rays,computer aided
      detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more
      responsive to treatment. The investigators would also like to see if early detection will
      reduce the incidence of symptomatic advanced lung cancer compared to no screening in former
      and current smokers with or without a family history of lung cancer who are 40-75 years old.
The fight against lung cancer is waged on three major fronts: prevention, detection and
      treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT
      scan can detect disease earlier when treatment is more effective. If we improve the detection
      of disease, we will see if screening reduces the incidence of symptomatic advanced lung
      cancer relative to no screening in people at high risk to develop lung cancer.
observational model: Cohort
time perspective: Prospective
measure: The sensitivities of chest x-ray with CAD and chest CT
time frame: One year after scan
description: The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.
measure: Disease-specific mortality between screening with chest x-ray and CAD versus no screening
time frame: One year after scan
description: Mortality rate in screening x-ray vs CAD
measure: All-cause mortality rate between screening with chest x-ray and CAD versus no screening
time frame: One year after scan
description: All cause mortality rate
measure: Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls
time frame: One year after scan
description: Time between randomization and symptom
measure: Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population
time frame: One year after scan
description: Cancer detection rate between chest x-ray and CAD
measure: The quality of life between screening with chest x-ray and CAD versus no screening.
time frame: One year after scan
description: Quality of life between the chest x-ray group and the CAD group
arm group label: all enrolled subjects
description: Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples.
intervention type: Device
intervention name: chest x-ray with or without CAD, lose dose CT scan
description: PA view, low dose CT scan
arm group label: all enrolled subjects
other name: CAD
other name: computer aided detection
Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for
      plasma and buffy coat retrieval
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Micheal Phillips, M.D.
role: Study Chair
affiliation: The Cleveland Clinic
last name: Moulay Meziane, MD
role: Principal Investigator
affiliation: Chair of Thoracic Imaging
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Moulay Meziane, MD
investigator title: Principal Investigator
mesh term: Lung Neoplasms