<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/NCT03284632</url>
  </required_header>
  <id_info>
    <org_study_id>2017NTLS040</org_study_id>
    <nct_id>NCT03284632</nct_id>
  </id_info>
  <brief_title>e-Cigarette - DNA Adducts</brief_title>
  <official_title>e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the level of toxicity of e-cigarette use compared to smokers and&#xD;
      nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally,&#xD;
      the study will look at the effect of varying voltage levels for e-cigarette users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or&#xD;
      tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area.&#xD;
      This research will be conducted at the Tobacco Research Programs at the University of&#xD;
      Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone&#xD;
      screen, participants will be invited to attend orientation screening visit in the clinic&#xD;
      where consent will be obtained and subjects will complete forms about their tobacco and&#xD;
      e-cigarette use and medical history. Subjects who eligible will be asked to return for six&#xD;
      visits over the course of six months.&#xD;
&#xD;
      At these appointments, subjects will provide biological specimen samples (buccal cells, urine&#xD;
      and blood). Saliva will be collected before and after a smoking or vaping session. Non-users&#xD;
      will only have 1 saliva collection.&#xD;
&#xD;
      Subjects will be asked for information pertaining to and e-cigarette and tobacco use and&#xD;
      overall health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2017</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>DNA Adducts</measure>
    <time_frame>6 months</time_frame>
    <description>Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary 8-iso-PGF-2α</measure>
    <time_frame>6 months</time_frame>
    <description>Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary PGEM</measure>
    <time_frame>6 months</time_frame>
    <description>Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>6 months</time_frame>
    <description>Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNE</measure>
    <time_frame>6 months</time_frame>
    <description>Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">217</enrollment>
  <condition>Smoking</condition>
  <condition>Cigarette Smoking</condition>
  <condition>Electronic Cigarettes</condition>
  <arm_group>
    <arm_group_label>Smokers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette users</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-smokers</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Buffy Coat, Serum, Plasma, Urine, Buccal Cells, Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited locally within reasonable distance from the University of&#xD;
        Minnesota.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good physical health with no unstable medical conditions; Able to provide written&#xD;
             informed consent; Stable and good mental health;&#xD;
&#xD;
        Meet criteria for 1 of three groups:&#xD;
&#xD;
          1. Regular smokers confirmed by CO;&#xD;
&#xD;
          2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users&#xD;
&#xD;
          3. Non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable medical condition Not willing to attend visits&#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 Hecht, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco</keyword>
  <keyword>E-Cigarettes</keyword>
  <keyword>Toxicants</keyword>
  <keyword>Formaldehyde DNA Adducts</keyword>
  <keyword>Oxidative Damage</keyword>
  <!-- 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/NCT03284632
org study id: 2017NTLS040
nct id: NCT03284632
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the level of toxicity of e-cigarette use compared to smokers and
      nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally,
      the study will look at the effect of varying voltage levels for e-cigarette users.
In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or
      tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area.
      This research will be conducted at the Tobacco Research Programs at the University of
      Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone
      screen, participants will be invited to attend orientation screening visit in the clinic
      where consent will be obtained and subjects will complete forms about their tobacco and
      e-cigarette use and medical history. Subjects who eligible will be asked to return for six
      visits over the course of six months.

      At these appointments, subjects will provide biological specimen samples (buccal cells, urine
      and blood). Saliva will be collected before and after a smoking or vaping session. Non-users
      will only have 1 saliva collection.

      Subjects will be asked for information pertaining to and e-cigarette and tobacco use and
      overall health.
observational model: Cohort
time perspective: Prospective
measure: DNA Adducts
time frame: 6 months
description: Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
measure: Urinary 8-iso-PGF-2α
time frame: 6 months
description: Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period
measure: Urinary PGEM
time frame: 6 months
description: Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period
measure: C-reactive protein
time frame: 6 months
description: Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period
measure: TNE
time frame: 6 months
description: Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period
arm group label: Smokers
arm group label: E-cigarette users
arm group label: Non-smokers
Buffy Coat, Serum, Plasma, Urine, Buccal Cells, Saliva
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 Hecht, Phd
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor