<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/NCT01700257</url>
  </required_header>
  <id_info>
    <org_study_id>Oncimmune-2550</org_study_id>
    <nct_id>NCT01700257</nct_id>
  </id_info>
  <brief_title>Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker</brief_title>
  <official_title>Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is&#xD;
      asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already&#xD;
      have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has&#xD;
      recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer&#xD;
      deaths are not prevented with LDCT screening alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this trial, the addition of a blood biomarker test is being combined with early LDCT to&#xD;
      determine if screening with combination may result in detection of more lung cancer at an&#xD;
      earlier stage of disease.The study will also assess if the blood test is able to detect lung&#xD;
      cancers in high risk individuals when the LDCT is negative for cancer. There will be&#xD;
      health-economic costs included in the final analysis of study data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</primary_completion_date>
  <phase>N/A</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>CT alone vs. both Early CDT-Lung test and CT scan.</measure>
    <time_frame>One year</time_frame>
    <description>Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Value of Early CDT-lung test in detecting cancer</measure>
    <time_frame>One year</time_frame>
    <description>Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health Economics</measure>
    <time_frame>One Year</time_frame>
    <description>Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1361</enrollment>
  <condition>High Risk of Developing Lung Cancer</condition>
  <arm_group>
    <arm_group_label>CT scan &amp; Early CDT Lung test</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Every study participant receives a CT scan &amp; Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CT scan &amp; Early CDT Lung test</intervention_name>
    <arm_group_label>CT scan &amp; Early CDT Lung test</arm_group_label>
    <other_name>Every study participant receives a CT scan &amp; Early CDT-Lung test (biomarker blood test)</other_name>
    <other_name>for lung cancer screening purposes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT scan &amp; Early CDT Lung test</intervention_name>
    <arm_group_label>CT scan &amp; Early CDT Lung test</arm_group_label>
    <other_name>CT scan &amp; Early CDT-Lung test (biomarker blood test)for lung cancer screening.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smokers or former smokers&#xD;
&#xD;
          -  At least 20 pack year history of smoking&#xD;
&#xD;
          -  Ages 50 - 75&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had a CT scan of chest within last 24 months&#xD;
&#xD;
          -  History of any cancer within 10 yrs (except skin cancer or cervical cancer)&#xD;
&#xD;
          -  A serious illness that decreases life expectancy to less than 5 years&#xD;
&#xD;
          -  Any current use of Oxygen&#xD;
&#xD;
          -  Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery&#xD;
             for a lung lesion&#xD;
&#xD;
          -  Severe COPD or dyspnea that would prevent lung surgery or stereotactic body&#xD;
             radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James R Jett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Jewish Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>December 29, 2020</last_update_submitted>
  <last_update_submitted_qc>December 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer screening</keyword>
  <keyword>Smokers or former smokers</keyword>
  <keyword>Family history of lung cancer</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/NCT01700257
org study id: Oncimmune-2550
nct id: NCT01700257
lead sponsor: 
has dmc: Yes
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is
      asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already
      have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has
      recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer
      deaths are not prevented with LDCT screening alone.
In this trial, the addition of a blood biomarker test is being combined with early LDCT to
      determine if screening with combination may result in detection of more lung cancer at an
      earlier stage of disease.The study will also assess if the blood test is able to detect lung
      cancers in high risk individuals when the LDCT is negative for cancer. There will be
      health-economic costs included in the final analysis of study data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: CT alone vs. both Early CDT-Lung test and CT scan.
time frame: One year
description: Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
measure: Value of Early CDT-lung test in detecting cancer
time frame: One year
description: Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.
measure: Health Economics
time frame: One Year
description: Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.
arm group label: CT scan & Early CDT Lung test
arm group type: Other
description: Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.
intervention type: Radiation
intervention name: CT scan & Early CDT Lung test
arm group label: CT scan & Early CDT Lung test
other name: Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test)
other name: for lung cancer screening purposes
intervention type: Other
intervention name: CT scan & Early CDT Lung test
arm group label: CT scan & Early CDT Lung test
other name: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: James R Jett, MD
role: Principal Investigator
affiliation: National Jewish Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms