<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/NCT01692951</url>
  </required_header>
  <id_info>
    <org_study_id>12-306</org_study_id>
    <nct_id>NCT01692951</nct_id>
  </id_info>
  <brief_title>Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer</brief_title>
  <official_title>Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the performance of serum free fatty acids as biomarkers for the&#xD;
      identification of lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will compare the concentration of free fatty acids and their metabolites between patients&#xD;
      with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy&#xD;
      will be assessed for potential predictors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare Concentration of Fatty Acids and Their Metabolites</measure>
    <time_frame>At the time of diagnosis, prior to the initiation of lung cancer treatment</time_frame>
    <description>Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">220</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Biomarkers</condition>
  <condition>Fatty Acids</condition>
  <arm_group>
    <arm_group_label>Lung adenocarcinoma patients</arm_group_label>
    <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control matched to adenocarcinoma</arm_group_label>
    <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lung squamous cell carcinoma patients</arm_group_label>
    <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control matched to squamous cell</arm_group_label>
    <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>serum sample</intervention_name>
    <description>Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
    <arm_group_label>Control matched to adenocarcinoma</arm_group_label>
    <arm_group_label>Control matched to squamous cell</arm_group_label>
    <arm_group_label>Lung adenocarcinoma patients</arm_group_label>
    <arm_group_label>Lung squamous cell carcinoma patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be sampled for FFA metabolites&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patient samples are retrieved from the Cleveland Clinic Biobank.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 40 to 80&#xD;
&#xD;
          -  Lung adenocarcinoma with pathological diagnosis&#xD;
&#xD;
          -  Lung squamous cell carcinoma with pathological diagnosis&#xD;
&#xD;
          -  Control patients should have at least one of the following criteria: (1) current or&#xD;
             ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a&#xD;
             history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Lung cancer patient without serum sample before the initiation of treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Sessler, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</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>April 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>February 21, 2017</results_first_submitted>
  <results_first_submitted_qc>April 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 20, 2017</results_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Outcomes Research Consortium</investigator_affiliation>
    <investigator_full_name>d sessler</investigator_full_name>
    <investigator_title>MD</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lung Adenocarcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="P2">
          <title>Control Matched to Adenocarcinoma</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="P3">
          <title>Lung Squamous Cell Carcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="P4">
          <title>Control Matched to Squamous Cell</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lung Adenocarcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="B2">
          <title>Control Matched to Adenocarcinoma</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="B3">
          <title>Lung Squamous Cell Carcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="B4">
          <title>Control Matched to Squamous Cell</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="B5">
          <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="37"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="54"/>
            <count group_id="B5" value="220"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="66" spread="11"/>
                    <measurement group_id="B2" value="65" spread="6"/>
                    <measurement group_id="B3" value="70" spread="9"/>
                    <measurement group_id="B4" value="68" spread="6"/>
                    <measurement group_id="B5" value="66" spread="7"/>
                  </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="13"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of lung cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>COPD</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Amount of Cigarette Smoking as Pack-year</title>
          <units>pack-year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="25" upper_limit="56"/>
                    <measurement group_id="B2" value="40" lower_limit="26" upper_limit="56"/>
                    <measurement group_id="B3" value="38" lower_limit="25" upper_limit="50"/>
                    <measurement group_id="B4" value="39" lower_limit="24" upper_limit="60"/>
                    <measurement group_id="B5" value="40" lower_limit="25" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Compare Concentration of Fatty Acids and Their Metabolites</title>
        <description>Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.</description>
        <time_frame>At the time of diagnosis, prior to the initiation of lung cancer treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lung Adenocarcinoma Patients</title>
            <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
          </group>
          <group group_id="O2">
            <title>Control Matched to Adenocarcinoma</title>
            <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
          </group>
          <group group_id="O3">
            <title>Lung Squamous Cell Carcinoma Patients</title>
            <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
          </group>
          <group group_id="O4">
            <title>Control Matched to Squamous Cell</title>
            <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Concentration of Fatty Acids and Their Metabolites</title>
          <description>Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.</description>
          <units>mg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Arachidonic Acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.70" lower_limit="4.62" upper_limit="7.74"/>
                    <measurement group_id="O2" value="2.95" lower_limit="2.26" upper_limit="4.63"/>
                    <measurement group_id="O3" value="4.24" lower_limit="3.65" upper_limit="5.05"/>
                    <measurement group_id="O4" value="3.18" lower_limit="2.43" upper_limit="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Linoleic Acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" lower_limit="0.46" upper_limit="0.73"/>
                    <measurement group_id="O2" value="0.34" lower_limit="0.22" upper_limit="0.52"/>
                    <measurement group_id="O3" value="0.44" lower_limit="0.33" upper_limit="0.64"/>
                    <measurement group_id="O4" value="0.32" lower_limit="0.23" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroperoxyoctadecadienoyl phosphatidylcholine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" lower_limit="13.1" upper_limit="33.3"/>
                    <measurement group_id="O2" value="17.9" lower_limit="12.3" upper_limit="23.6"/>
                    <measurement group_id="O3" value="18" lower_limit="16" upper_limit="29"/>
                    <measurement group_id="O4" value="18" lower_limit="14" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroxyoctadecadienoylphosphatidylcholine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.9" upper_limit="5.5"/>
                    <measurement group_id="O2" value="7.1" lower_limit="3.2" upper_limit="13.1"/>
                    <measurement group_id="O3" value="4" lower_limit="2" upper_limit="18"/>
                    <measurement group_id="O4" value="9" lower_limit="4" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Azelaoyl platelet activating factor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.3" upper_limit="0.8"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0.3" upper_limit="0.8"/>
                    <measurement group_id="O4" value="0.5" lower_limit="0.3" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Azelaoyl phosphatidylcholine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O3" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O4" value="0.2" lower_limit="0.2" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C18-lysophospholipid platelet activating factor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="8.6" upper_limit="15.7"/>
                    <measurement group_id="O2" value="16.5" lower_limit="13.1" upper_limit="19.8"/>
                    <measurement group_id="O3" value="13" lower_limit="11" upper_limit="14"/>
                    <measurement group_id="O4" value="17" lower_limit="13" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C16-lyso-phosphatidylcholine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.2" upper_limit="17.8"/>
                    <measurement group_id="O2" value="9.8" lower_limit="6.6" upper_limit="30.6"/>
                    <measurement group_id="O3" value="12" lower_limit="6" upper_limit="52"/>
                    <measurement group_id="O4" value="13" lower_limit="7" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C16-lysophospholipid platelet activating factor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.1"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="0.1"/>
                    <measurement group_id="O4" value="0.1" lower_limit="0.0" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5-hydroxyeicosatetraenoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="0.04" upper_limit="0.07"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0.02" upper_limit="0.05"/>
                    <measurement group_id="O3" value="0.04" lower_limit="0.03" upper_limit="0.05"/>
                    <measurement group_id="O4" value="0.03" lower_limit="0.02" upper_limit="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11-hydroxyeicosatetraenoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" lower_limit="0.03" upper_limit="0.11"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0.02" upper_limit="0.05"/>
                    <measurement group_id="O3" value="0.04" lower_limit="0.04" upper_limit="0.06"/>
                    <measurement group_id="O4" value="0.03" lower_limit="0.02" upper_limit="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-hydroxyeicosatetraenoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" lower_limit="0.44" upper_limit="1.73"/>
                    <measurement group_id="O2" value="0.23" lower_limit="0.13" upper_limit="0.57"/>
                    <measurement group_id="O3" value="0.42" lower_limit="0.18" upper_limit="0.95"/>
                    <measurement group_id="O4" value="0.22" lower_limit="0.13" upper_limit="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15-hydroxyeicosatetraenoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" lower_limit="0.01" upper_limit="0.02"/>
                    <measurement group_id="O2" value="0.01" lower_limit="0.00" upper_limit="0.01"/>
                    <measurement group_id="O3" value="0.01" lower_limit="0.01" upper_limit="0.02"/>
                    <measurement group_id="O4" value="0.01" lower_limit="0.01" upper_limit="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-hydroxyoctadecadienoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" lower_limit="0.30" upper_limit="0.97"/>
                    <measurement group_id="O2" value="0.58" lower_limit="0.32" upper_limit="0.87"/>
                    <measurement group_id="O3" value="0.52" lower_limit="0.36" upper_limit="0.68"/>
                    <measurement group_id="O4" value="0.51" lower_limit="0.34" upper_limit="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13-hydroxyoctadecadienoic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" lower_limit="0.27" upper_limit="0.62"/>
                    <measurement group_id="O2" value="0.48" lower_limit="0.30" upper_limit="0.69"/>
                    <measurement group_id="O3" value="0.49" lower_limit="0.38" upper_limit="0.73"/>
                    <measurement group_id="O4" value="0.44" lower_limit="0.33" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Lung Adenocarcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="E2">
          <title>Control Matched to Adenocarcinoma</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="E3">
          <title>Lung Squamous Cell Carcinoma Patients</title>
          <description>Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
        <group group_id="E4">
          <title>Control Matched to Squamous Cell</title>
          <description>Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.&#xD;
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Daniel Sessler, MD</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>216-444-4900</phone>
      <email>sessled@ccf.org</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/NCT01692951
org study id: 12-306
nct id: NCT01692951
lead sponsor: 
has dmc: No
This study aims to evaluate the performance of serum free fatty acids as biomarkers for the
      identification of lung cancer.
We will compare the concentration of free fatty acids and their metabolites between patients
      with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy
      will be assessed for potential predictors.
observational model: Case-Control
time perspective: Retrospective
measure: Compare Concentration of Fatty Acids and Their Metabolites
time frame: At the time of diagnosis, prior to the initiation of lung cancer treatment
description: Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.
arm group label: Lung adenocarcinoma patients
description: Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
arm group label: Control matched to adenocarcinoma
description: Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
arm group label: Lung squamous cell carcinoma patients
description: Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
arm group label: Control matched to squamous cell
description: Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
intervention type: Other
intervention name: serum sample
description: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
arm group label: Control matched to adenocarcinoma
arm group label: Control matched to squamous cell
arm group label: Lung adenocarcinoma patients
arm group label: Lung squamous cell carcinoma patients
Blood will be sampled for FFA metabolites
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Daniel Sessler, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Outcomes Research Consortium
investigator full name: d sessler
investigator title: MD
mesh term: Lung Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 