<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/NCT03293758</url>
  </required_header>
  <id_info>
    <org_study_id>12-00855</org_study_id>
    <secondary_id>R21CA183887</secondary_id>
    <nct_id>NCT03293758</nct_id>
  </id_info>
  <brief_title>Food and Microbiome Longitudinal Investigation (FAMiLI)</brief_title>
  <official_title>Food and Microbiome Longitudinal Investigation (FAMiLI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</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 NYU Human Microbiome Study Cohort is designed to improve understanding of the role of&#xD;
      human microbiome in health and disease. This study will serve as a critical NYU biorepository&#xD;
      resource for research on human genetics and the microbiome in health and disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 16, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2033</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Demographic</measure>
    <time_frame>5 Years</time_frame>
    <description>sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.</measure>
    <time_frame>5 Years</time_frame>
    <description>Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">14000</enrollment>
  <condition>Cancer</condition>
  <condition>Cardiovascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects in the United States identified at NYU clinics, community organizations, and&#xD;
        online participant databases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of long term antibiotics.&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiyoung Ahn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dia Beggs</last_name>
    <phone>646-501-3396</phone>
    <email>dia.beggs@nyulangone.org</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Dia Beggs</last_name>
      <phone>646-501-3396</phone>
      <email>dia.beggs@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Jiyoung Ahn, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 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>Cardiovascular Diseases</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/NCT03293758
org study id: 12-00855
secondary id: R21CA183887
nct id: NCT03293758
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of
      human microbiome in health and disease. This study will serve as a critical NYU biorepository
      resource for research on human genetics and the microbiome in health and disease
observational model: Cohort
time perspective: Prospective
measure: Demographic
time frame: 5 Years
description: sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.
measure: Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.
time frame: 5 Years
description: Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyoung Ahn, PhD
role: Principal Investigator
affiliation: NYU Langone Health
last name: Dia Beggs
phone: 646-501-3396
email: dia.beggs@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases