Hepatitis C Infection in World Trade Center Responders

Hepatitis C Infection Clinical Trial

Official title:

Hepatitis C Infection in World Trade Center Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982993
• Other study ID #: GCO 16-0912
• Status: Completed
• Start date: December 2016
• Est. completion date: July 12, 2018

Study information

• Verified date: February 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3906
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 51 Years to 72 Years

Eligibility

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:

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Infection

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Hepatitis C virus infection	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	Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.	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