Hepatitis C Infection in World Trade Center Responders

NCT02982993 | Completed

• 1 other identifier: GCO 16-0912
• Study Type: observational
• Target: 3,906
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C Infection

Keywords

hepatitis C virus; linkage-to-care; World Trade Center Health Program cohort; Baby Boomer; risk factors for hepatitis C virus infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.

  2 years

Study Arms (1)

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

Eligibility Criteria

• Age: 51 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Centers for Disease Control and Prevention: collaborator
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)