<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/NCT01719068</url>
  </required_header>
  <id_info>
    <org_study_id>H12-01812</org_study_id>
    <nct_id>NCT01719068</nct_id>
  </id_info>
  <brief_title>Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos</brief_title>
  <official_title>Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BC Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>British Columbia Cancer Agency</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study that aims to develop a lung cancer screening program for workers in&#xD;
      British Columbia, Canada exposed to asbestos who are at risk of developing lung&#xD;
      cancer/pleural mesothelioma. This is high risk population is at of respiratory system&#xD;
      diseases as a result of their occupational exposures. Additionally, knowledge garnered from&#xD;
      this study will allow us to develop other studies that will further our understanding of&#xD;
      asbestos related lung cancer and mesothelioma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Mesothelioma</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Workers exposed to asbestos</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Workers in British Columbia who have been exposed to asbestos.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women or men age 50 to 79 years&#xD;
&#xD;
          -  history of exposure to asbestos at work and one or more of the following:&#xD;
&#xD;
               -  lung cancer risk ≥2% over 3 years or&#xD;
&#xD;
               -  asbestosis or pleural plaques on a chest x-ray or&#xD;
&#xD;
               -  abnormal auto-antibodies level using the EarlyCDT test&#xD;
&#xD;
          -  Capable of providing informed consent for screening procedures (low dose spiral CT,&#xD;
             lung function, blood biomarkers).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition, such as severe heart disease (e.g. unstable angina, chronic&#xD;
             congestive heart failure), acute or chronic respiratory failure, or any disorder, that&#xD;
             in the opinion of the physician unlikely to benefit from screening due to shortened&#xD;
             life-expectancy from co-existing illnesses&#xD;
&#xD;
          -  Have been previously diagnosed with mesothelioma&#xD;
&#xD;
          -  Have had other cancer within the past 5 years with the exception of the following&#xD;
             cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ&#xD;
             (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must&#xD;
             have ended &gt;6 months before registration into this study&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unwilling to have a low dose CT scan of chest&#xD;
&#xD;
          -  Unwilling to sign a consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Lam</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Cancer Agency</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon Gee</last_name>
    <phone>604-675-8089</phone>
    <email>sgee@bccancer.bc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>British Columbia Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z1L3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon Gee</last_name>
      <phone>604-675-8089</phone>
      <email>sgee@bccancer.bc.ca</email>
    </contact>
    <investigator>
      <last_name>Stephen Lam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annette McWilliams, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tawimas Shaipanich, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mesothelioma</keyword>
  <keyword>Lung Cancer</keyword>
  <keyword>Early Detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</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/NCT01719068
org study id: H12-01812
nct id: NCT01719068
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot study that aims to develop a lung cancer screening program for workers in
      British Columbia, Canada exposed to asbestos who are at risk of developing lung
      cancer/pleural mesothelioma. This is high risk population is at of respiratory system
      diseases as a result of their occupational exposures. Additionally, knowledge garnered from
      this study will allow us to develop other studies that will further our understanding of
      asbestos related lung cancer and mesothelioma.
observational model: Cohort
time perspective: Prospective
measure: Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma
time frame: 3 years
arm group label: Workers exposed to asbestos
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Lam
role: Principal Investigator
affiliation: British Columbia Cancer Agency
last name: Sharon Gee
phone: 604-675-8089
email: sgee@bccancer.bc.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant