<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/NCT03029325</url>
  </required_header>
  <id_info>
    <org_study_id>1999P-004935</org_study_id>
    <secondary_id>5P30CA006516-50</secondary_id>
    <nct_id>NCT03029325</nct_id>
  </id_info>
  <brief_title>Molecular and Genetic Analysis of Lung Cancer</brief_title>
  <official_title>Molecular and Genetic Analysis of Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators use a genome-wide approach within a case-control design to identify SNPs that&#xD;
      show evidence of association with lung cancer risk and survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators also investigate how genetic variants may affect cancer treatment, at various&#xD;
      stages of disease development, in order to determine prognostic and predictive factors for&#xD;
      survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 1993</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival among patients at different stages of lung cancer and treatment will be measured using questionnaires along with medical chart data to monitor treatment and disease progression</measure>
    <time_frame>20 years</time_frame>
    <description>Study lung cancer development in a case control study. We will look at three separate outcome measures specified below</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>20 years</time_frame>
    <description>Measurement from time of diagnosis to death will be obtained</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>20 years</time_frame>
    <description>Time of diagnosis to disease progression (measured by metastasis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment toxicities</measure>
    <time_frame>20 years</time_frame>
    <description>Effects on ECOG and physical sequelae from treatment (radiation, chemotherapy and other treatment modalities will be analyzed)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Lung Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and tissue samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Lung cancer cases and healthy controls are recruited from Massachusetts General Hospital&#xD;
        patient population. Cases come from Thoracic Surgery or Cancer Center. Controls are usually&#xD;
        spouses or friends of cases, or in some cases unrelated to a specific case.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy controls: participants without evidence of any cancer&#xD;
&#xD;
          -  cases: pathology proven primary lung cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David C Christiani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard TH Chan School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Christiani, MD</last_name>
    <phone>617-726-9274</phone>
    <email>dchris@hsph.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Shafer, MPH</last_name>
    <phone>6177269274</phone>
    <email>ashafer@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Shafer, MPH</last_name>
      <phone>617-726-9274</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 30, 2015</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David Christopher Christiani</investigator_full_name>
    <investigator_title>Elkan Blout Professor at Harvard TH Chan School of Public Health, Professor of Medicine Harvard Medical School</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03029325
org study id: 1999P-004935
secondary id: 5P30CA006516-50
nct id: NCT03029325
lead sponsor: 
collaborator: 
has dmc: No
Investigators use a genome-wide approach within a case-control design to identify SNPs that
      show evidence of association with lung cancer risk and survival.
Investigators also investigate how genetic variants may affect cancer treatment, at various
      stages of disease development, in order to determine prognostic and predictive factors for
      survival.
observational model: Case-Only
time perspective: Prospective
measure: Survival among patients at different stages of lung cancer and treatment will be measured using questionnaires along with medical chart data to monitor treatment and disease progression
time frame: 20 years
description: Study lung cancer development in a case control study. We will look at three separate outcome measures specified below
measure: Overall survival
time frame: 20 years
description: Measurement from time of diagnosis to death will be obtained
measure: Progression-free survival
time frame: 20 years
description: Time of diagnosis to disease progression (measured by metastasis)
measure: Treatment toxicities
time frame: 20 years
description: Effects on ECOG and physical sequelae from treatment (radiation, chemotherapy and other treatment modalities will be analyzed)
Blood and tissue samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David C Christiani, MD
role: Principal Investigator
affiliation: Harvard TH Chan School of Public Health
last name: David Christiani, MD
phone: 617-726-9274
email: dchris@hsph.harvard.edu
last name: Andrea Shafer, MPH
phone: 6177269274
email: ashafer@partners.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David Christopher Christiani
investigator title: Elkan Blout Professor at Harvard TH Chan School of Public Health, Professor of Medicine Harvard Medical School
mesh term: Lung Neoplasms
sharing ipd: No