Hepatitis C Infection in World Trade Center Responders

February 1, 2019 updated by: Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3906

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The World Trade Center Health Program is a longitudinal cohort of World Trade Center rescue and recovery workers who participated in the World Trade Center Screening, Monitoring, and Treatment Program at the Icahn School of Medicine at Mount Sinai in New York, New York. Eligible World Trade Center responders were those who had worked or volunteered in lower Manhattan, or the Staten island landfill or barge-loading piers for 4 hours or more from September 11, 2001, to September 14, 2001; 24 hours or more during September, 2001; 80 hours or more from September, 2001, to December, 2001. Persons enrolled in the World Trade Center Health Program and were born from 1945-1965 are eligible.

Description

Inclusion Criteria:

  • Member of the World Trade Center Health Program at the Icahn School of Medicine at Mount Sinai
  • Born during 1945-1965

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
WTC responders participating in HCV infection study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hepatitis C virus infection
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

  • Principal Investigator: Stephanie H Factor, MD,MPH, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Paolo Bofetta, MD, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

July 12, 2018

Study Completion (Actual)

July 12, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 16-0912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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