<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/NCT02982993</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 16-0912</org_study_id>
    <nct_id>NCT02982993</nct_id>
  </id_info>
  <brief_title>Hepatitis C Infection in World Trade Center Responders</brief_title>
  <official_title>Hepatitis C Infection in World Trade Center Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Occupational Safety and Health (NIOSH/CDC)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study provides Hepatitis C virus screening to the members of the World Trade Center&#xD;
      Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965,&#xD;
      and linkage to care for those found infected. The study will also determine if exposure to&#xD;
      human remains, blood and/or bodily fluids during the World Trade Center Health Program&#xD;
      activities are associated with Hepatitis C virus infection. These findings would be relevant&#xD;
      to the larger United States population, especially to persons born during 1945-1965 who are&#xD;
      at high risk of Hepatitis C virus infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the project is to determine if the World Trade Center Health Program cohort is&#xD;
      at an increased risk of Hepatitis C virus infection, determine if human exposure to human&#xD;
      remains, blood and/or body fluids during the World Trade Center recovery activities is&#xD;
      associated with increased risk of Hepatitis C virus infection, and to determine if referral&#xD;
      to a co-located site for Hepatitis C virus care is associated with improved linkage to&#xD;
      Hepatitis C virus care in the members of the World Trade Center Health Program born during&#xD;
      1945 through 1965.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 12, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Prevalence of Hepatitis C virus infection</measure>
    <time_frame>2 years</time_frame>
    <description>The investigator will measure the prevalence of Hepatitis C virus infection in 3900 World Trade Center Health program members to test the hypothesis that World Trade Center Health program members have an increased risk of Hepatitis C virus infection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.</measure>
    <time_frame>2 years</time_frame>
    <description>The investigator will test the measure of association between exposure to human remains, blood and / or bodily fluids and risk of hepatitis C virus infection, while adjusting for type of activity during work at World Trade Center site and use of personal protective equipment.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3906</enrollment>
  <condition>Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>WTC responders participating in HCV infection study</arm_group_label>
    <description>Members of the World Trade Center Health Program cohort born from 1945 to 1965 who choose to participate in this research study on hepatitis C infection</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The World Trade Center Health Program is a longitudinal cohort of World Trade Center rescue&#xD;
        and recovery workers who participated in the World Trade Center Screening, Monitoring, and&#xD;
        Treatment Program at the Icahn School of Medicine at Mount Sinai in New York, New York.&#xD;
        Eligible World Trade Center responders were those who had worked or volunteered in lower&#xD;
        Manhattan, or the Staten island landfill or barge-loading piers for 4 hours or more from&#xD;
        September 11, 2001, to September 14, 2001; 24 hours or more during September, 2001; 80&#xD;
        hours or more from September, 2001, to December, 2001. Persons enrolled in the World Trade&#xD;
        Center Health Program and were born from 1945-1965 are eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Member of the World Trade Center Health Program at the Icahn School of Medicine at&#xD;
             Mount Sinai&#xD;
&#xD;
          -  Born during 1945-1965&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie H Factor, MD,MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo Bofetta, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hepatitis C virus</keyword>
  <keyword>linkage-to-care</keyword>
  <keyword>World Trade Center Health Program cohort</keyword>
  <keyword>Baby Boomer</keyword>
  <keyword>risk factors for hepatitis C virus infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</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/NCT02982993
org study id: GCO 16-0912
nct id: NCT02982993
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study provides Hepatitis C virus screening to the members of the World Trade Center
      Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965,
      and linkage to care for those found infected. The study will also determine if exposure to
      human remains, blood and/or bodily fluids during the World Trade Center Health Program
      activities are associated with Hepatitis C virus infection. These findings would be relevant
      to the larger United States population, especially to persons born during 1945-1965 who are
      at high risk of Hepatitis C virus infection.
The purpose of the project is to determine if the World Trade Center Health Program cohort is
      at an increased risk of Hepatitis C virus infection, determine if human exposure to human
      remains, blood and/or body fluids during the World Trade Center recovery activities is
      associated with increased risk of Hepatitis C virus infection, and to determine if referral
      to a co-located site for Hepatitis C virus care is associated with improved linkage to
      Hepatitis C virus care in the members of the World Trade Center Health Program born during
      1945 through 1965.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Hepatitis C virus infection
time frame: 2 years
description: The investigator will measure the prevalence of Hepatitis C virus infection in 3900 World Trade Center Health program members to test the hypothesis that World Trade Center Health program members have an increased risk of Hepatitis C virus infection.
measure: Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.
time frame: 2 years
description: The investigator will test the measure of association between exposure to human remains, blood and / or bodily fluids and risk of hepatitis C virus infection, while adjusting for type of activity during work at World Trade Center site and use of personal protective equipment.
arm group label: WTC responders participating in HCV infection study
description: Members of the World Trade Center Health Program cohort born from 1945 to 1965 who choose to participate in this research study on hepatitis C infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 51 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephanie H Factor, MD,MPH
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Paolo Bofetta, MD, MPH
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No