Hepatitis C Infection in World Trade Center Responders

NCT ID: NCT02982993

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3906 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

51 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

National Institute for Occupational Safety and Health (NIOSH/CDC)

FED

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie H Factor, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Paolo Bofetta, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 16-0912

Identifier Type: -

Identifier Source: org_study_id

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