<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/NCT03302637</url>
  </required_header>
  <id_info>
    <org_study_id>12-00721</org_study_id>
    <nct_id>NCT03302637</nct_id>
  </id_info>
  <brief_title>Oral Microbiome and Pancreatic Cancer</brief_title>
  <official_title>Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This is a prospective population based study to examine the relationship of oral and&#xD;
      pancreatic microbiome, and their functions, to pancreatic cancer risk.&#xD;
&#xD;
      The identification of specific oral bacteria and their functional relationship to pancreatic&#xD;
      cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could&#xD;
      provide a new microbially-based research paradigm, possibly leading to new drug targets for&#xD;
      this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive&#xD;
      biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk&#xD;
      of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic&#xD;
      preventions, with antibiotic therapy aimed at eradicating the specific species associated&#xD;
      with increased cancer risk or, alternatively, combined with probiotics to introduce species&#xD;
      that are associated with a decreased cancer risk. Thus, the study outcomes will lead to&#xD;
      actionable means for pancreatic cancer prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A history of periodontal disease and the presence of circulating antibodies to selected oral&#xD;
      pathogens have been associated with increased risk of pancreatic cancer; however, direct&#xD;
      relationships of oral microbes with pancreatic cancer have not been evaluated in prospective&#xD;
      studies. Investigators examine the relationship of oral microbiota with subsequent risk of&#xD;
      pancreatic cancer in a large nested case-control study.&#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>Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.</measure>
    <time_frame>4 Years</time_frame>
    <description>For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites. To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">732</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>subjects with histology-confirmed incident pancreatic cancer, with no prior history of cancer (except non-melanoma skin cancer), a valid consent, and pre-diagnostic oral wash samples.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>selected by incidence density sampling63 among cohort members who had no cancer prior to selection, provided a valid consent and an oral wash. Controls were frequency matched to cases by cohort, age at cohort entry (5 year), sex, race, and calendar year of cohort entry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>16S rRNA gene sequencing assay</intervention_name>
    <description>extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Using DNA extracted from oral samples from these cohorts, 16S rRNA genes were amplified and&#xD;
      sequenced, followed by assignment of each sequence to a microbial taxa&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective&#xD;
        cohort studies, the American Cancer Society Cancer Prevention Study II and the National&#xD;
        Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>74 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 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</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>Pancreatic Neoplasms</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/NCT03302637
org study id: 12-00721
nct id: NCT03302637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective population based study to examine the relationship of oral and
      pancreatic microbiome, and their functions, to pancreatic cancer risk.

      The identification of specific oral bacteria and their functional relationship to pancreatic
      cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could
      provide a new microbially-based research paradigm, possibly leading to new drug targets for
      this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive
      biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk
      of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic
      preventions, with antibiotic therapy aimed at eradicating the specific species associated
      with increased cancer risk or, alternatively, combined with probiotics to introduce species
      that are associated with a decreased cancer risk. Thus, the study outcomes will lead to
      actionable means for pancreatic cancer prevention.
A history of periodontal disease and the presence of circulating antibodies to selected oral
      pathogens have been associated with increased risk of pancreatic cancer; however, direct
      relationships of oral microbes with pancreatic cancer have not been evaluated in prospective
      studies. Investigators examine the relationship of oral microbiota with subsequent risk of
      pancreatic cancer in a large nested case-control study.
observational model: Case-Control
time perspective: Prospective
measure: Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.
time frame: 4 Years
description: For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites. To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).
arm group label: Cases
description: subjects with histology-confirmed incident pancreatic cancer, with no prior history of cancer (except non-melanoma skin cancer), a valid consent, and pre-diagnostic oral wash samples.
arm group label: Control
description: selected by incidence density sampling63 among cohort members who had no cancer prior to selection, provided a valid consent and an oral wash. Controls were frequency matched to cases by cohort, age at cohort entry (5 year), sex, race, and calendar year of cohort entry.
intervention type: Other
intervention name: 16S rRNA gene sequencing assay
description: extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
arm group label: Cases
arm group label: Control
Using DNA extracted from oral samples from these cohorts, 16S rRNA genes were amplified and
      sequenced, followed by assignment of each sequence to a microbial taxa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 74 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: Pancreatic Neoplasms