<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/NCT03304132</url>
  </required_header>
  <id_info>
    <org_study_id>10-01834</org_study_id>
    <nct_id>NCT03304132</nct_id>
  </id_info>
  <brief_title>The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer</brief_title>
  <official_title>The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic&#xD;
      species. The oral microbiome is comprised of 44% named species, 12% isolates representing&#xD;
      unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies&#xD;
      (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes,&#xD;
      Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7,&#xD;
      Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these&#xD;
      observations have been mainly based on data generated from traditional Sanger sequencing, the&#xD;
      diversity of oral microbiome is highly likely underestimated. Application of high throughput&#xD;
      sequencing to the oral microbiome similar to the scale of the microbiome studies of other&#xD;
      body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to&#xD;
      obtain data essential for understanding the diversity and community structure of the oral&#xD;
      microbiome in health and disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American&#xD;
      Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC&#xD;
      cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for&#xD;
      study (ACS. PLCO), gender, ethnic background, and age, within 10 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 1992</start_date>
  <completion_date type="Actual">December 1, 2010</completion_date>
  <primary_completion_date type="Actual">December 1, 2010</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>16S rRNA gene survey approach for microbiome characterization</measure>
    <time_frame>4 Years</time_frame>
    <description>Data alignment and clustering to determine microbiome species diversity</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">560</enrollment>
  <condition>Oral Cancer</condition>
  <arm_group>
    <arm_group_label>Upper aerodigestive squamous cell cancers (UADSCC) cases</arm_group_label>
    <description>From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach</intervention_name>
    <description>The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Upper aerodigestive squamous cell cancers (UADSCC) cases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classification of Oral Microbiome Using taxonomic approach</intervention_name>
    <description>The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Upper aerodigestive squamous cell cancers (UADSCC) cases</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The American Cancer Society Cancer (ACS) Prevention Study II Nutrition Cohort (CPS-II) was&#xD;
        established in 1992; the cohort includes over 86,000 men and 97,000 women from 21 U.S.&#xD;
        states who completed a mailed questionnaire in 1992. In total, 72 UADSCC were eligible for&#xD;
        study, with completed informed consent and prediagnostic oral wash collection.&#xD;
&#xD;
        The Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial is a randomized&#xD;
        controlled trial of approximately 155,000 men and women. Participants are randomized to&#xD;
        either a screening or control arm. n total, 68 UADSCC were eligible for study, including&#xD;
        completed informed consent and prediagnostic oral wash collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:&#xD;
&#xD;
          -  The American Cancer Society Cancer Prevention Study II (CPS-II)&#xD;
&#xD;
          -  The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>92 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiyoung Ahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Microbiome</keyword>
  <keyword>reflux disorders</keyword>
  <keyword>esophageal microbiome</keyword>
  <keyword>Alcohol Use</keyword>
  <keyword>Tobacco Use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Squamous Cell</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03304132
org study id: 10-01834
nct id: NCT03304132
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic
      species. The oral microbiome is comprised of 44% named species, 12% isolates representing
      unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies
      (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes,
      Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7,
      Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these
      observations have been mainly based on data generated from traditional Sanger sequencing, the
      diversity of oral microbiome is highly likely underestimated. Application of high throughput
      sequencing to the oral microbiome similar to the scale of the microbiome studies of other
      body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to
      obtain data essential for understanding the diversity and community structure of the oral
      microbiome in health and disease.
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American
      Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC
      cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for
      study (ACS. PLCO), gender, ethnic background, and age, within 10 years.
observational model: Case-Control
time perspective: Prospective
measure: 16S rRNA gene survey approach for microbiome characterization
time frame: 4 Years
description: Data alignment and clustering to determine microbiome species diversity
arm group label: Upper aerodigestive squamous cell cancers (UADSCC) cases
description: From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),
arm group label: Controls
description: From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),
intervention type: Other
intervention name: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach
description: The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.
arm group label: Controls
arm group label: Upper aerodigestive squamous cell cancers (UADSCC) cases
intervention type: Other
intervention name: Classification of Oral Microbiome Using taxonomic approach
description: The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.
arm group label: Controls
arm group label: Upper aerodigestive squamous cell cancers (UADSCC) cases
140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 92 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyoung Ahn, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mouth Neoplasms
mesh term: Neoplasms, Squamous Cell
mesh term: Carcinoma, Squamous Cell
sharing ipd: No