<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/NCT01696968</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2012-01756</org_study_id>
    <secondary_id>NCI-2012-01756</secondary_id>
    <secondary_id>CDR0000078532</secondary_id>
    <secondary_id>NCI-P93-0050</secondary_id>
    <secondary_id>PLCO-1</secondary_id>
    <secondary_id>PLCO-Lung</secondary_id>
    <nct_id>NCT01696968</nct_id>
  </id_info>
  <brief_title>Screening for Lung Cancer in Older Patients (PLCO Screening Trial)</brief_title>
  <official_title>Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <brief_summary>
    <textblock>
      This clinical trial studies whether screening methods used to diagnose cancer of the&#xD;
      prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening&#xD;
      tests may help doctors find cancer cells early and plan better treatment for lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in&#xD;
      women and men aged 55-74 at entry.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess screening variables, other than mortality, for each of the interventions&#xD;
      including sensitivity, specificity, and positive predictive value.&#xD;
&#xD;
      II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the&#xD;
      mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as&#xD;
      intermediate endpoints.&#xD;
&#xD;
      IV. To conduct biomolecular and genetic research into factors associated with cancer&#xD;
      carcinogenesis and promotion, as well as the early detection of these factors.&#xD;
&#xD;
      OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender,&#xD;
      and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms&#xD;
      (control vs screening).&#xD;
&#xD;
      ARM I (Control): Participants receive standard medical care. Participants complete a Diet&#xD;
      History Questionnaire (DHQ) at baseline.&#xD;
&#xD;
      ARM II (Lung Screening): Participants undergo a chest x-ray (one postero-anterior view) at&#xD;
      baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional&#xD;
      chest x-ray at year 3. A scheduling and tracking procedure is implemented to ensure regular&#xD;
      attendance at repeat screens for participants screened negative or for those who are&#xD;
      designated suspicious or positive at screening but for whom subsequent diagnostic procedures&#xD;
      do not reveal lung cancer (follow-up diagnostic procedures are through their own medical care&#xD;
      environment). Participants diagnosed with lung cancer via a screening test are referred for&#xD;
      treatment in accordance with current accepted practice for appropriate stage of disease,&#xD;
      patient age, and medical condition; a procedure is provided for contact with qualified&#xD;
      medical personnel to insure appropriate therapy.&#xD;
&#xD;
      Participants complete a Baseline Questionnaire (BQF/M) to assess smoking status. Participants&#xD;
      complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update&#xD;
      (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed&#xD;
      to each participant annually for 13 years to identify all prevalent and incident lung cancers&#xD;
      as all deaths that occur among both screened and control subjects during the trial.&#xD;
&#xD;
      After completion of screening, participants are followed up for at least 13 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 16, 1993</start_date>
  <primary_completion_date type="Actual">May 21, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lung Cancer Deaths</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung Cancer Death Rates</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Deaths From All Causes</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Deaths from all causes were compared between the lung screening arm and the usual care arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death Rates From All Causes</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Cancer Incidence</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Lung cancer diagnoses confirmed by medical record abstraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Cancer Incidence Rates</measure>
    <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
    <description>Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of Diagnostic Evaluation Following a Positive Screening Test</measure>
    <time_frame>One year from screening examination</time_frame>
    <description>Number of positive screens with complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T0 (Baseline) CXR Screening Results</measure>
    <time_frame>T0 (at study entry)</time_frame>
    <description>Postero-anterior view chest radiograph (CXR) result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1 CXR Screening Results</measure>
    <time_frame>T1 (one year after entry)</time_frame>
    <description>Postero-anterior view chest radiograph (CXR) result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T2 CXR Screening Results</measure>
    <time_frame>T2 (two years after entry)</time_frame>
    <description>Postero-anterior view chest radiograph (CXR) result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T3 CXR Screening Results</measure>
    <time_frame>T3 (three years after entry)</time_frame>
    <description>Postero-anterior view chest radiograph (CXR) result</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154901</enrollment>
  <condition>Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive standard medical care. Participants complete a DHQ at baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lung Screening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening Questionnaire Administration</intervention_name>
    <description>Undergo questionnaire assessments</description>
    <arm_group_label>Lung Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>X-Ray Imaging</intervention_name>
    <description>Undergo a chest x-ray</description>
    <arm_group_label>Lung Screening</arm_group_label>
    <other_name>Conventional X-Ray</other_name>
    <other_name>Diagnostic Radiology</other_name>
    <other_name>Medical Imaging, X-Ray</other_name>
    <other_name>Plain film radiographs</other_name>
    <other_name>Radiographic Imaging</other_name>
    <other_name>Radiographic imaging procedure (procedure)</other_name>
    <other_name>Radiography</other_name>
    <other_name>RG</other_name>
    <other_name>Static X-Ray</other_name>
    <other_name>X-Ray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and women who at the time of randomization are less than 55 or greater than or&#xD;
             equal to 75 years of age&#xD;
&#xD;
          -  Individuals undergoing treatment for cancer at this time, excluding basal-cell and&#xD;
             squamous-cell skin cancer&#xD;
&#xD;
          -  Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or&#xD;
             ovary (women only)&#xD;
&#xD;
               -  This includes primary or metastatic PLCO cancers&#xD;
&#xD;
          -  Individuals with previous surgical removal of the entire colon, one lung, or the&#xD;
             entire prostate (men only)&#xD;
&#xD;
               -  Until October 1996, women with previous surgical removal of both ovaries were&#xD;
                  excluded from the trial. In order to increase the enrollment of women into the&#xD;
                  trial, beginning in October 1996, these women were no longer excluded for this&#xD;
                  reason.&#xD;
&#xD;
          -  Individuals who are participating in another cancer screening or cancer primary&#xD;
             prevention trial&#xD;
&#xD;
          -  Males who have taken Proscar/Propecia/finasteride in the past 6 months&#xD;
&#xD;
               -  NOTE: Individuals who are already enrolled in the trial when their physician&#xD;
                  prescribes finasteride are not prevented from taking this medication. As a&#xD;
                  result, these participants will continue to be screened and followed just as&#xD;
                  those participants who are not on finasteride.&#xD;
&#xD;
               -  NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO&#xD;
                  Screening Trial.&#xD;
&#xD;
               -  Prior to April 1, 1999 women were excluded from the trial if they were currently&#xD;
                  taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of&#xD;
                  April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have&#xD;
                  or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from&#xD;
                  participation.&#xD;
&#xD;
          -  Individuals who are unwilling or unable to sign the informed consent form&#xD;
&#xD;
          -  Males who have had more than one PSA blood test in the past three years&#xD;
&#xD;
          -  Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past&#xD;
             three years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine D Berg</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>August 30, 2013</results_first_submitted>
  <results_first_submitted_qc>June 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 21, 2014</results_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 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>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).</recruitment_details>
      <pre_assignment_details>Participants signed a study informed consent prior to being randomized to a study arm.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Participants receive standard medical care.</description>
        </group>
        <group group_id="P2">
          <title>Lung Screening</title>
          <description>Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77456"/>
                <participants group_id="P2" count="77445"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76255"/>
                <participants group_id="P2" count="70633"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1201"/>
                <participants group_id="P2" count="6812"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Cancer Before Rand. (Lung Screening)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Died Before Randomization</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Died Before ASU (Control)</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused ASU (Control)</title>
              <participants_list>
                <participants group_id="P1" count="920"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused Screen (Lung Screening)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6796"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Participants receive standard medical care.</description>
        </group>
        <group group_id="B2">
          <title>Lung Screening</title>
          <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="77456"/>
            <count group_id="B2" value="77445"/>
            <count group_id="B3" value="154901"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49612"/>
                    <measurement group_id="B2" value="49634"/>
                    <measurement group_id="B3" value="99246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27844"/>
                    <measurement group_id="B2" value="27811"/>
                    <measurement group_id="B3" value="55655"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.6" spread="5.4"/>
                    <measurement group_id="B2" value="62.6" spread="5.4"/>
                    <measurement group_id="B3" value="62.6" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39111"/>
                    <measurement group_id="B2" value="39105"/>
                    <measurement group_id="B3" value="78216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38345"/>
                    <measurement group_id="B2" value="38340"/>
                    <measurement group_id="B3" value="76685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77456"/>
                    <measurement group_id="B2" value="77445"/>
                    <measurement group_id="B3" value="154901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lung Cancer Deaths</title>
        <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Cancer Deaths</title>
          <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.</description>
          <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1230"/>
                    <measurement group_id="O2" value="1213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Deaths From All Causes</title>
        <description>Deaths from all causes were compared between the lung screening arm and the usual care arm.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Deaths From All Causes</title>
          <description>Deaths from all causes were compared between the lung screening arm and the usual care arm.</description>
          <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11061"/>
                    <measurement group_id="O2" value="10827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death Rates From All Causes</title>
        <description>Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Death Rates From All Causes</title>
          <description>Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.</description>
          <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
          <units>Deaths per 10,000 PY</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.1"/>
                    <measurement group_id="O2" value="125.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Cancer Incidence</title>
        <description>Lung cancer diagnoses confirmed by medical record abstraction.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Cancer Incidence</title>
          <description>Lung cancer diagnoses confirmed by medical record abstraction.</description>
          <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1620"/>
                    <measurement group_id="O2" value="1696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Cancer Incidence Rates</title>
        <description>Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Cancer Incidence Rates</title>
          <description>Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.</description>
          <population>All participants were analyzed. An intention-to-treat analysis was performed.</population>
          <units>Diagnoses per 10,000 PY</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2"/>
                    <measurement group_id="O2" value="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications of Diagnostic Evaluation Following a Positive Screening Test</title>
        <description>Number of positive screens with complications.</description>
        <time_frame>One year from screening examination</time_frame>
        <population>The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Complications of Diagnostic Evaluation Following a Positive Screening Test</title>
          <description>Number of positive screens with complications.</description>
          <population>The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.</population>
          <units>Positive screens w/ complications</units>
          <param>Number</param>
          <units_analyzed>Positive Screens with Follow-up</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12889"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Positive Screens with Follow-up</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17475"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>When DE Led to Lung Cancer Diagnosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>When DE Did Not Lead to Lung Cancer Diagnosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T0 (Baseline) CXR Screening Results</title>
        <description>Postero-anterior view chest radiograph (CXR) result</description>
        <time_frame>T0 (at study entry)</time_frame>
        <population>All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>T0 (Baseline) CXR Screening Results</title>
          <description>Postero-anterior view chest radiograph (CXR) result</description>
          <population>All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67037"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inadequate screen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1 CXR Screening Results</title>
        <description>Postero-anterior view chest radiograph (CXR) result</description>
        <time_frame>T1 (one year after entry)</time_frame>
        <population>All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>T1 CXR Screening Results</title>
          <description>Postero-anterior view chest radiograph (CXR) result</description>
          <population>All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64706"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inadequate screen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lung Cancer Death Rates</title>
        <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.</description>
        <time_frame>Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants receive standard medical care.</description>
          </group>
          <group group_id="O2">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Cancer Death Rates</title>
          <description>Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.</description>
          <units>Deaths per 10,000 PY</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77456"/>
                <count group_id="O2" value="77445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2"/>
                    <measurement group_id="O2" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T2 CXR Screening Results</title>
        <description>Postero-anterior view chest radiograph (CXR) result</description>
        <time_frame>T2 (two years after entry)</time_frame>
        <population>All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>T2 CXR Screening Results</title>
          <description>Postero-anterior view chest radiograph (CXR) result</description>
          <population>All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63305"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inadequate screen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T3 CXR Screening Results</title>
        <description>Postero-anterior view chest radiograph (CXR) result</description>
        <time_frame>T3 (three years after entry)</time_frame>
        <population>All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Screening</title>
            <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
          </group>
        </group_list>
        <measure>
          <title>T3 CXR Screening Results</title>
          <description>Postero-anterior view chest radiograph (CXR) result</description>
          <population>All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2908"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inadequate screen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During each annual screening visit.</time_frame>
      <desc>These events are solely those prompted by the screening examination.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lung Screening</title>
          <description>Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as &quot;smokers&quot; undergo an additional chest x-ray at year 3.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77445"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77445"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul F. Pinsky, Ph.D.</name_or_title>
      <organization>Early Detection Research Group, NCI, NIH</organization>
      <phone>301-496-8544</phone>
      <email>pinskyp@mail.nih.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01696968
org study id: NCI-2012-01756
secondary id: NCI-2012-01756
secondary id: CDR0000078532
secondary id: NCI-P93-0050
secondary id: PLCO-1
secondary id: PLCO-Lung
nct id: NCT01696968
lead sponsor: 
This clinical trial studies whether screening methods used to diagnose cancer of the
      prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening
      tests may help doctors find cancer cells early and plan better treatment for lung cancer.
PRIMARY OBJECTIVES:

      I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in
      women and men aged 55-74 at entry.

      SECONDARY OBJECTIVES:

      I. To assess screening variables, other than mortality, for each of the interventions
      including sensitivity, specificity, and positive predictive value.

      II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the
      mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as
      intermediate endpoints.

      IV. To conduct biomolecular and genetic research into factors associated with cancer
      carcinogenesis and promotion, as well as the early detection of these factors.

      OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender,
      and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms
      (control vs screening).

      ARM I (Control): Participants receive standard medical care. Participants complete a Diet
      History Questionnaire (DHQ) at baseline.

      ARM II (Lung Screening): Participants undergo a chest x-ray (one postero-anterior view) at
      baseline and annually for 2 years. Participants classified as "smokers" undergo an additional
      chest x-ray at year 3. A scheduling and tracking procedure is implemented to ensure regular
      attendance at repeat screens for participants screened negative or for those who are
      designated suspicious or positive at screening but for whom subsequent diagnostic procedures
      do not reveal lung cancer (follow-up diagnostic procedures are through their own medical care
      environment). Participants diagnosed with lung cancer via a screening test are referred for
      treatment in accordance with current accepted practice for appropriate stage of disease,
      patient age, and medical condition; a procedure is provided for contact with qualified
      medical personnel to insure appropriate therapy.

      Participants complete a Baseline Questionnaire (BQF/M) to assess smoking status. Participants
      complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update
      (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed
      to each participant annually for 13 years to identify all prevalent and incident lung cancers
      as all deaths that occur among both screened and control subjects during the trial.

      After completion of screening, participants are followed up for at least 13 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Lung Cancer Deaths
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
measure: Lung Cancer Death Rates
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
measure: Deaths From All Causes
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Deaths from all causes were compared between the lung screening arm and the usual care arm.
measure: Death Rates From All Causes
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.
measure: Lung Cancer Incidence
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Lung cancer diagnoses confirmed by medical record abstraction.
measure: Lung Cancer Incidence Rates
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
description: Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.
measure: Complications of Diagnostic Evaluation Following a Positive Screening Test
time frame: One year from screening examination
description: Number of positive screens with complications.
measure: T0 (Baseline) CXR Screening Results
time frame: T0 (at study entry)
description: Postero-anterior view chest radiograph (CXR) result
measure: T1 CXR Screening Results
time frame: T1 (one year after entry)
description: Postero-anterior view chest radiograph (CXR) result
measure: T2 CXR Screening Results
time frame: T2 (two years after entry)
description: Postero-anterior view chest radiograph (CXR) result
measure: T3 CXR Screening Results
time frame: T3 (three years after entry)
description: Postero-anterior view chest radiograph (CXR) result
arm group label: Control
arm group type: No Intervention
description: Participants receive standard medical care. Participants complete a DHQ at baseline.
arm group label: Lung Screening
arm group type: Active Comparator
description: Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.
intervention type: Other
intervention name: Screening Questionnaire Administration
description: Undergo questionnaire assessments
arm group label: Lung Screening
intervention type: Procedure
intervention name: X-Ray Imaging
description: Undergo a chest x-ray
arm group label: Lung Screening
other name: Conventional X-Ray
other name: Diagnostic Radiology
other name: Medical Imaging, X-Ray
other name: Plain film radiographs
other name: Radiographic Imaging
other name: Radiographic imaging procedure (procedure)
other name: Radiography
other name: RG
other name: Static X-Ray
other name: X-Ray
criteria: 
gender: All
minimum age: 55 Years
maximum age: 74 Years
healthy volunteers: No
last name: Christine D Berg
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 