<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/NCT01673711</url>
  </required_header>
  <id_info>
    <org_study_id>2011NTUC092</org_study_id>
    <secondary_id>NCI-2012-01148</secondary_id>
    <nct_id>NCT01673711</nct_id>
  </id_info>
  <brief_title>Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer</brief_title>
  <official_title>Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk&#xD;
      for lung cancer. Studying samples of urine in the laboratory from smokers who are at high&#xD;
      risk for lung cancer may help doctors learn more about biomarkers related to cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol&#xD;
      (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial&#xD;
      metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell&#xD;
      Park Cancer Institute (RPCI).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for&#xD;
      laboratory studies for 6 hours after dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary deuterated phenanthrene tetraol level</measure>
    <time_frame>Up to 6 hours</time_frame>
    <description>A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PheT:HOPhe ratio</measure>
    <time_frame>Up to 6 hours</time_frame>
    <description>A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia</measure>
    <time_frame>Up to 6 hours</time_frame>
    <description>A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">350</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Squamous Lung Dysplasia</condition>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Basic Science (deuterated phenanthrene tetraol)</arm_group_label>
    <description>Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>deuterated phenanthrene tetraol</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Basic Science (deuterated phenanthrene tetraol)</arm_group_label>
    <other_name>[D10] phenanthrene</other_name>
    <other_name>phenanthrene-D10</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pharmacological study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Basic Science (deuterated phenanthrene tetraol)</arm_group_label>
    <other_name>pharmacological studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Basic Science (deuterated phenanthrene tetraol)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, blood, buccal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy current and former smokers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Current or former smoker&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy&#xD;
             (white light and/or autofluorescence) conducted less than or equal to 10 years prior&#xD;
             to registration&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
          -  Able to provide written informed consent indicating an understanding of the nature of&#xD;
             the study&#xD;
&#xD;
          -  Willing to comply with study requirements, including taking [D10]phenanthrene in water&#xD;
             with 20% ethanol&#xD;
&#xD;
          -  No previous history of aerodigestive cancer&#xD;
&#xD;
          -  Not currently undergoing treatment for any cancers. Exception: basal cell or squamous&#xD;
             cell skin cancer&#xD;
&#xD;
          -  Not currently taking any other investigational agents&#xD;
&#xD;
          -  No history of allergic reaction to [D10]phenanthrene or similar compounds&#xD;
&#xD;
          -  No major medical comorbidities, for example, renal dysfunction, heart function, and&#xD;
             diabetes, to be adjudicated by study physicians&#xD;
&#xD;
          -  Not a former or recovering alcoholic&#xD;
&#xD;
          -  No use of metronidazole or antabuse less than or equal to 7 days prior to&#xD;
             [D10]phenanthrene dosing, as they could potentially interact with ethanol&#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>Stephen S Hecht, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</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>
    <mesh_term>Tobacco Use Disorder</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/NCT01673711
org study id: 2011NTUC092
secondary id: NCI-2012-01148
nct id: NCT01673711
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk
      for lung cancer. Studying samples of urine in the laboratory from smokers who are at high
      risk for lung cancer may help doctors learn more about biomarkers related to cancer.
PRIMARY OBJECTIVES:

      I. To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol
      (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial
      metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell
      Park Cancer Institute (RPCI).

      OUTLINE:

      Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for
      laboratory studies for 6 hours after dosing.
observational model: Other
time perspective: Prospective
measure: Urinary deuterated phenanthrene tetraol level
time frame: Up to 6 hours
description: A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
measure: PheT:HOPhe ratio
time frame: Up to 6 hours
description: A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
measure: Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia
time frame: Up to 6 hours
description: A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
arm group label: Basic Science (deuterated phenanthrene tetraol)
description: Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
intervention type: Drug
intervention name: deuterated phenanthrene tetraol
description: Given PO
arm group label: Basic Science (deuterated phenanthrene tetraol)
other name: [D10] phenanthrene
other name: phenanthrene-D10
intervention type: Drug
intervention name: pharmacological study
description: Correlative studies
arm group label: Basic Science (deuterated phenanthrene tetraol)
other name: pharmacological studies
intervention type: Drug
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Basic Science (deuterated phenanthrene tetraol)
Urine, blood, buccal swab
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: Stephen S Hecht, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Tobacco Use Disorder