<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/NCT04430712</url>
  </required_header>
  <id_info>
    <org_study_id>2020P000361</org_study_id>
    <nct_id>NCT04430712</nct_id>
  </id_info>
  <brief_title>Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume</brief_title>
  <official_title>Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment&#xD;
      leads to an accelerated progression of atherosclerosis in patients with lung cancer.&#xD;
      Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being&#xD;
      targeted for cancer are critical negative regulators of atherosclerosis in animal and&#xD;
      cellular models. Aortic plaque progression will be compared between cases (on ICI) and&#xD;
      controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will&#xD;
      be matched for age, cancer type and stage and cardiovascular risk factors. Traditional&#xD;
      markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination&#xD;
      therapy, number of cycles, occurrence of immune-related adverse events, chest radiation,&#xD;
      steroid use) will be associated with the change in aortic plaque volume.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">August 22, 2022</completion_date>
  <primary_completion_date type="Actual">August 12, 2022</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>Change in aortic plaque volume</measure>
    <time_frame>Three years</time_frame>
    <description>The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with non-small cell lung cancer from a single tertiary care center in the United&#xD;
        States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cases:&#xD;
&#xD;
          -  Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.&#xD;
&#xD;
          -  Available contrast enhanced CT scans of the chest both immediately pre-ICI (&lt; 1 month)&#xD;
             and latest follow-up.&#xD;
&#xD;
        Controls:&#xD;
&#xD;
          -  Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk&#xD;
             factor matched to cases.&#xD;
&#xD;
          -  Available contrast enhanced CT scan of the chest at two time-points at a similar&#xD;
             interval between scans as the cases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Tomas G. Neilan, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Immune Checkpoint Inhibitor</keyword>
  <keyword>Atherosclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04430712
org study id: 2020P000361
nct id: NCT04430712
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment
      leads to an accelerated progression of atherosclerosis in patients with lung cancer.
      Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being
      targeted for cancer are critical negative regulators of atherosclerosis in animal and
      cellular models. Aortic plaque progression will be compared between cases (on ICI) and
      controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will
      be matched for age, cancer type and stage and cardiovascular risk factors. Traditional
      markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination
      therapy, number of cycles, occurrence of immune-related adverse events, chest radiation,
      steroid use) will be associated with the change in aortic plaque volume.
observational model: Case-Control
time perspective: Retrospective
measure: Change in aortic plaque volume
time frame: Three years
description: The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Tomas G. Neilan, MD
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Plaque, Atherosclerotic