Hepatitis C InfectionNCT02982993
Hepatitis C Infection in World Trade Center Responders
An observational study of Hepatitis C Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 51 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Infection
- How many people
- 3,906 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 12 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Member of the World Trade Center Health Program at the Icahn School of Medicine at Mount Sinai
- Born during 1945-1965
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Stephanie H Factor, MD,MPH, Principal investigator, Icahn School of Medicine at Mount SinaiPaolo Bofetta, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982993
- Sponsor's protocol ID
- GCO 16-0912
- Status last verified
- Feb 2019
- First submitted
- 2 Dec 2016
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Infection in World Trade Center Responders
- ClinicalTrials.gov ID
- NCT02982993
- Acronym / sponsor ID
- GCO 16-0912
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,906 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Dec 2016
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 51 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Member of the World Trade Center Health Program at the Icahn School of Medicine at Mount Sinai
- Born during 1945-1965
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie H Factor, MD,MPH principal investigator
Icahn School of Medicine at Mount Sinai
Paolo Bofetta, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hepatitis C virus infection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.