<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/NCT03297996</url>
  </required_header>
  <id_info>
    <org_study_id>11-01377</org_study_id>
    <nct_id>NCT03297996</nct_id>
  </id_info>
  <brief_title>Study of Gut Microbiome and Colorectal Tumors</brief_title>
  <official_title>The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer</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>
      Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing&#xD;
      of stool samples. Investigators compared gut microbiota diversity, overall composition, and&#xD;
      normalized taxon abundance among these groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer is a heterogeneous disease arising from at least two precursors-the&#xD;
      conventional adenoma (CA) and the serrated polyp. A relationship between the human gut&#xD;
      microbiota and colorectal cancer has been shown; however, its relationship to the different&#xD;
      early precursors of colorectal cancer is understudied. This study tested, for the first time,&#xD;
      the relationship of the gut microbiota to specific colorectal polyp types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2011</start_date>
  <completion_date type="Actual">April 25, 2015</completion_date>
  <primary_completion_date type="Actual">April 25, 2015</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>Prevalence and relative abundance of selected fecal microbial taxa</measure>
    <time_frame>2 Days</time_frame>
    <description>Quantitative polymerase chain reaction</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">540</enrollment>
  <condition>Serrated Polyp</condition>
  <condition>Hyperplastic Polyp</condition>
  <condition>Sessile Serrated Adenoma</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>SIT</arm_group_label>
    <description>Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NYU</arm_group_label>
    <description>New York University (NYU) Human Microbiome and Colorectal Tumor study</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mobio PowerSoil DNA Isolation Kit</intervention_name>
    <description>16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence</description>
    <arm_group_label>NYU</arm_group_label>
    <arm_group_label>SIT</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA was extracted from stool using the PowerLyzer PowerSoil Kit (Mo Bio Laboratory Inc., CA)&#xD;
      following the manufacturer's protocol. DNA was collected and eluted using silica columns&#xD;
      included with the PowerLyzer PowerSoil kit. Barcoded amplicons were generated covering the V4&#xD;
      region of the 16S rRNA gene using the F515/R806 primer pair.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        There are no enrollment restrictions based on race or ethnic origins. Vulnerable subjects&#xD;
        such as pregnant women and children will not be involved in this study. We will not ask&#xD;
        subjects about sensitive topics such as Mental Health, drug/alcohol abuse, or others that&#xD;
        fall in this category.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both men and women who have visited a gastroenterologist or surgeon, aged 18 or older&#xD;
             will be included in this study.&#xD;
&#xD;
          -  Both men and women residents in the United States, aged 18 or older will be included&#xD;
             in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant will be excluded from participating in this study&#xD;
&#xD;
          -  Subjects on ongoing antibiotic therapy will be excluded from participating in this&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 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>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Polyps</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/NCT03297996
org study id: 11-01377
nct id: NCT03297996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing
      of stool samples. Investigators compared gut microbiota diversity, overall composition, and
      normalized taxon abundance among these groups.
Colorectal cancer is a heterogeneous disease arising from at least two precursors-the
      conventional adenoma (CA) and the serrated polyp. A relationship between the human gut
      microbiota and colorectal cancer has been shown; however, its relationship to the different
      early precursors of colorectal cancer is understudied. This study tested, for the first time,
      the relationship of the gut microbiota to specific colorectal polyp types.
observational model: Case-Control
time perspective: Prospective
measure: Prevalence and relative abundance of selected fecal microbial taxa
time frame: 2 Days
description: Quantitative polymerase chain reaction
arm group label: SIT
description: Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)
arm group label: NYU
description: New York University (NYU) Human Microbiome and Colorectal Tumor study
intervention type: Diagnostic Test
intervention name: Mobio PowerSoil DNA Isolation Kit
description: 16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence
arm group label: NYU
arm group label: SIT
DNA was extracted from stool using the PowerLyzer PowerSoil Kit (Mo Bio Laboratory Inc., CA)
      following the manufacturer's protocol. DNA was collected and eluted using silica columns
      included with the PowerLyzer PowerSoil kit. Barcoded amplicons were generated covering the V4
      region of the 16S rRNA gene using the F515/R806 primer pair.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiyoung Ahn, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Adenoma
mesh term: Polyps