<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/NCT03028558</url>
  </required_header>
  <id_info>
    <org_study_id>1512016796</org_study_id>
    <nct_id>NCT03028558</nct_id>
  </id_info>
  <brief_title>Biology of the Oral Epithelium of E-Cigarette Smokers</brief_title>
  <official_title>Biology of the Oral Epithelium of E-Cigarette Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize&#xD;
      nicotine and other flavor constituents. Despite the increasing use of EC, little attention&#xD;
      has been paid to their possible adverse effects on human health. Theoretically, the risk&#xD;
      relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The&#xD;
      hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the&#xD;
      oral epithelium, the first cell population exposed to inhaled EC vapors. Using a&#xD;
      cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and&#xD;
      ethnicity-matched never smokers, the investigators propose to assess the oral epithelium&#xD;
      obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC&#xD;
      study cohort will be restricted to young adults (age 21-35 yr) with no prior history of&#xD;
      tobacco smoking, but who have smoked EC for &gt;6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is compelling evidence to support this hypothesis: (1) EC vapors contain nicotine, the&#xD;
      oral epithelium expresses nicotine receptors, and exposure of epithelia to nicotine activates&#xD;
      the nicotine pathway; (2) EC vapors also contain chemical contaminants that can potentially&#xD;
      effect oral epithelial biology; and (3) in vitro studies suggest that EC vapors modify&#xD;
      epithelial biology and data generated by our laboratory demonstrates that even a brief, acute&#xD;
      exposure of healthy nonsmokers to EC vapors induces significant changes in the airway&#xD;
      epithelial transcriptome, including the expression of genes in the nicotine and p53 pathways.&#xD;
      With the knowledge that disordering of cell biology occurs long before clinical disease,the&#xD;
      investigators will evaluate the oral epithelium at the transcriptome (mRNA and miRNA) levels.&#xD;
      They will then identify gene(s)/pathways/communities disordered by EC vapors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2016</start_date>
  <completion_date type="Actual">January 21, 2021</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The biology of participants oral epithelial cells</measure>
    <time_frame>1-2 months</time_frame>
    <description>Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The biology of the genes of the oral epithelium</measure>
    <time_frame>1-2 months</time_frame>
    <description>Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>HEALTHY VOLUNTEER RESEARCH SUBJECTS</arm_group_label>
    <description>Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population.&#xD;
Between the ages of 21-35 years old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HEALTHY E-CIGARETTE SMOKING SUBJECTS</arm_group_label>
    <description>Criteria is identical to the healthy never-smoker group except that they must have a history of smoking e-cigarettes &gt;5 days/wk for a minimum of 6 months with no prior traditional tobacco exposure.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens collected may include blood, urine and oral epithelium samples from consenting&#xD;
      subjects. Subjects will include both e-cigarette smoking individuals and healthy control&#xD;
      subjects.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators plan recruit the EC smoking (also called &quot;vaping&quot;) population, and have&#xD;
        experience recruiting from the extensive network of EC shops and vaping &quot;bars&quot; in the New&#xD;
        York City metropolitan area, providing ample access to young adult, sole EC smokers. The&#xD;
        control groups will be age-, gender- and ethnicity-matched healthy nonsmokers. Based on our&#xD;
        experience with this population, the investigators know that the variables of EC smoking&#xD;
        history (brand, flavorings, length and extent of EC smoking history) demand that there is&#xD;
        sufficient &quot;n&quot; to power the analysis. In this regard, the study population will include&#xD;
        n=125, including n=100 EC smokers and a control group of n=25 healthy nonsmokers. Between&#xD;
        the ages of 21-35 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HEALTHY VOLUNTEER RESEARCH SUBJECTS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, ages 21 to 35&#xD;
&#xD;
          -  Must be capable of providing informed consent&#xD;
&#xD;
          -  Self-reported never-smokers of any type, including chewing tobacco, with current&#xD;
             smoking status validated by the absence of nicotine metabolites in urine (nicotine &lt;2&#xD;
             ng/ml and cotinine &lt;5 ng/ml)&#xD;
&#xD;
          -  No bleeding diathesis&#xD;
&#xD;
          -  Normal physical examination&#xD;
&#xD;
          -  Good overall health without history of oral or lung disease&#xD;
&#xD;
          -  Normal routine laboratory evaluation, including general hematologic studies, general&#xD;
             serologic/immunologic studies, general biochemical analyses, and urine analysis&#xD;
&#xD;
          -  Not taking any medications relevant to lung disease or having an effect on the airway&#xD;
             epithelium&#xD;
&#xD;
          -  Normal chest X-ray (PA and lateral)&#xD;
&#xD;
          -  Normal electrocardiogram (sinus bradycardia, premature atrial contractions are&#xD;
             permissible)&#xD;
&#xD;
          -  Females - not pregnant&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
               -  HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, ages 21 to 35&#xD;
&#xD;
          -  Must be capable of providing informed consent&#xD;
&#xD;
          -  E-cigarette smokers with current smoking status validated by nicotine metabolites in&#xD;
             urine (nicotine &gt;20 ng/ml and cotinine &gt;30 ng/ml)&#xD;
&#xD;
          -  No bleeding diathesis&#xD;
&#xD;
          -  Normal routine laboratory evaluation, including general hematologic studies, general&#xD;
             serologic/immunologic studies, general biochemical analyses, and urine analysis&#xD;
&#xD;
          -  Good overall health without history of oral disease&#xD;
&#xD;
          -  Normal spirometry&#xD;
&#xD;
          -  All individuals have chest X-ray (PA and lateral)&#xD;
&#xD;
          -  Normal electrocardiogram (sinus bradycardia, premature atrial contractions are&#xD;
             permissible)&#xD;
&#xD;
          -  Females - not pregnant&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HEALTHY VOLUNTEER RESEARCH SUBJECTS:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to meet the inclusion criteria&#xD;
&#xD;
          -  Have smoked any form of tobacco&#xD;
&#xD;
          -  Current marijuana smokers (within the last three months)&#xD;
&#xD;
          -  Current active infection or acute illness of any kind&#xD;
&#xD;
          -  Evidence of malignancy, including oral cancer&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
               -  HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Unable to meet the inclusion criteria&#xD;
&#xD;
          -  Have smoked any form of tobacco&#xD;
&#xD;
          -  Current marijuana smokers (within the last three months)&#xD;
&#xD;
          -  Current active infection or acute illness of any kind&#xD;
&#xD;
          -  Evidence of malignancy, including oral cancer&#xD;
&#xD;
          -  Current Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald G Crystal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Genetic Medicine, Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electronic Cigarettes</keyword>
  <keyword>Healthy Volunteers</keyword>
  <keyword>E-Cigarettes Smokers</keyword>
  <keyword>E-Cigarettes</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03028558
org study id: 1512016796
nct id: NCT03028558
lead sponsor: 
has dmc: No
Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize
      nicotine and other flavor constituents. Despite the increasing use of EC, little attention
      has been paid to their possible adverse effects on human health. Theoretically, the risk
      relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The
      hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the
      oral epithelium, the first cell population exposed to inhaled EC vapors. Using a
      cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and
      ethnicity-matched never smokers, the investigators propose to assess the oral epithelium
      obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC
      study cohort will be restricted to young adults (age 21-35 yr) with no prior history of
      tobacco smoking, but who have smoked EC for >6 months.
There is compelling evidence to support this hypothesis: (1) EC vapors contain nicotine, the
      oral epithelium expresses nicotine receptors, and exposure of epithelia to nicotine activates
      the nicotine pathway; (2) EC vapors also contain chemical contaminants that can potentially
      effect oral epithelial biology; and (3) in vitro studies suggest that EC vapors modify
      epithelial biology and data generated by our laboratory demonstrates that even a brief, acute
      exposure of healthy nonsmokers to EC vapors induces significant changes in the airway
      epithelial transcriptome, including the expression of genes in the nicotine and p53 pathways.
      With the knowledge that disordering of cell biology occurs long before clinical disease,the
      investigators will evaluate the oral epithelium at the transcriptome (mRNA and miRNA) levels.
      They will then identify gene(s)/pathways/communities disordered by EC vapors.
observational model: Case-Control
time perspective: Prospective
measure: The biology of participants oral epithelial cells
time frame: 1-2 months
description: Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products
measure: The biology of the genes of the oral epithelium
time frame: 1-2 months
description: Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products
arm group label: HEALTHY VOLUNTEER RESEARCH SUBJECTS
description: Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population.
Between the ages of 21-35 years old.
arm group label: HEALTHY E-CIGARETTE SMOKING SUBJECTS
description: Criteria is identical to the healthy never-smoker group except that they must have a history of smoking e-cigarettes >5 days/wk for a minimum of 6 months with no prior traditional tobacco exposure.
Specimens collected may include blood, urine and oral epithelium samples from consenting
      subjects. Subjects will include both e-cigarette smoking individuals and healthy control
      subjects.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald G Crystal, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided