xml: <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/NCT05973656</url>
    </required_header>
    <id_info>
      <org_study_id>SPH-2021-29712</org_study_id>
      <secondary_id>NCI-2022-09710</secondary_id>
      <nct_id>NCT05973656</nct_id>
    </id_info>
    <brief_title>Role of Acetaldehyde in the Development of Oral Cancer</brief_title>
    <official_title>Dissecting the Role of Acetaldehyde in Oral Carcinogenesis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Masonic Cancer Center, 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>Masonic Cancer Center, University of Minnesota</source>
    <oversight_info>
      <has_dmc>Yes</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 is a minimal risk intervention study where healthy volunteers and individuals with&#xD;
        Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive&#xD;
        biological samples at various time points. Biospecimens to be collected include saliva, oral&#xD;
        cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples&#xD;
        (5 mL each) will be optional and banked for future use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 8, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose</measure>
      <time_frame>Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose</time_frame>
      <description>Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Urine will be analyzed to confirm non-smoking status</measure>
      <time_frame>Prior to alcohol exposure</time_frame>
      <description>The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine will be analyzed to confirm non-smoking status</measure>
      <time_frame>Up to 6 hours after alcohol exposure</time_frame>
      <description>The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Alcohol-Related Carcinoma</condition>
    <condition>Fanconi Anemia</condition>
    <condition>Oral Cavity Carcinoma</condition>
    <arm_group>
      <arm_group_label>Group I (alcohol consumption)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II (biospecimen collection)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Alcohol</intervention_name>
      <description>Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).</description>
      <arm_group_label>Group I (alcohol consumption)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo saliva, mouthwash, and cheek brush collection</description>
      <arm_group_label>Group I (alcohol consumption)</arm_group_label>
      <arm_group_label>Group II (biospecimen collection)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Breath Test</intervention_name>
      <description>Undergo breathalyzer testing</description>
      <arm_group_label>Group I (alcohol consumption)</arm_group_label>
      <arm_group_label>Group II (biospecimen collection)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  21-45 years of age for alcohol drinkers&#xD;
  &#xD;
            -  Occasionally consume alcohol&#xD;
  &#xD;
            -  At least 1 drink per month for healthy volunteers&#xD;
  &#xD;
            -  At least 1 drink in the last 3 months for Fanconi anemia patients&#xD;
  &#xD;
            -  Meets one of the three criteria&#xD;
  &#xD;
            -  Healthy volunteer - ALDH2*1/1* homozygotes-not of Eastern Asian decent;&#xD;
  &#xD;
            -  Healthy volunteer - ALDH2*1/2* heterozygotes-of Eastern Asian decent and experience&#xD;
               flushing when drinking&#xD;
  &#xD;
            -  Individual's with Fanconi anemia (FA).&#xD;
  &#xD;
            -  18-45 years of age for non-drinkers&#xD;
  &#xD;
            -  Never consume alcohol/not had alcohol in the last 6 months&#xD;
  &#xD;
            -  Healthy volunteers.&#xD;
  &#xD;
            -  Non-smoker (smoked &lt; 100 cigarettes in a lifetime)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or nursing&#xD;
  &#xD;
            -  Taking any medication or drug that might affect alcohol use and absorption or that&#xD;
               might be affected by alcohol consumption&#xD;
  &#xD;
            -  Healthy volunteers who have taken any antibiotics in the last 3 months&#xD;
  &#xD;
            -  Currently consuming more than 21 drinks per week&#xD;
  &#xD;
            -  Have any history of alcohol or drug related problems&#xD;
  &#xD;
            -  Current or former tobacco/nicotine product(s) user&#xD;
  &#xD;
            -  Any regular use of tobacco/nicotine products or marijuana in the last year&#xD;
               (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)&#xD;
  &#xD;
            -  &quot;Trying&quot; or limited use of any nicotine products or marijuana in the last 1 month&#xD;
  &#xD;
            -  Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission&#xD;
               in the study will be delayed pending improved health&#xD;
  &#xD;
            -  Non-FA volunteers who have an unstable medical condition or condition that could be&#xD;
               affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)&#xD;
  &#xD;
            -  Experience severe adverse events (nausea, blacking out) when consuming even low doses&#xD;
               of alcohol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Balbo Silvia, PhD</last_name>
      <phone>612-624-4240</phone>
      <email>balbo006@umn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Masonic Cancer Center, University of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Balbo Silvia, PhD</last_name>
        <phone>612-624-4240</phone>
        <email>balbo006@umn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Carcinoma</mesh_term>
      <mesh_term>Fanconi Syndrome</mesh_term>
      <mesh_term>Fanconi Anemia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973656
  org study id: SPH-2021-29712
  secondary id: NCI-2022-09710
  nct id: NCT05973656
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a minimal risk intervention study where healthy volunteers and individuals with
        Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive
        biological samples at various time points. Biospecimens to be collected include saliva, oral
        cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples
        (5 mL each) will be optional and banked for future use.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
  time frame: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
  description: Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).
  measure: Urine will be analyzed to confirm non-smoking status
  time frame: Prior to alcohol exposure
  description: The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.
  measure: Urine will be analyzed to confirm non-smoking status
  time frame: Up to 6 hours after alcohol exposure
  description: The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.
  arm group label: Group I (alcohol consumption)
  arm group type: Experimental
  description: Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
  arm group label: Group II (biospecimen collection)
  arm group type: Active Comparator
  description: Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
  intervention type: Drug
  intervention name: Alcohol
  description: Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
  arm group label: Group I (alcohol consumption)
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo saliva, mouthwash, and cheek brush collection
  arm group label: Group I (alcohol consumption)
  arm group label: Group II (biospecimen collection)
  intervention type: Procedure
  intervention name: Breath Test
  description: Undergo breathalyzer testing
  arm group label: Group I (alcohol consumption)
  arm group label: Group II (biospecimen collection)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Balbo Silvia, PhD
  phone: 612-624-4240
  email: balbo006@umn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Fanconi Syndrome
  mesh term: Fanconi Anemia