Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01287000 |
| Other study ID # |
999911076 |
| Secondary ID |
11-E-N076 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2011 |
Study information
| Verified date |
February 5, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
- There has been little research on the long-term health effects from oil spills, even
though at least 10 percent of all oil tanker spills between 1970 and 2009 have affected
coastal populations. The Deepwater Horizon disaster, with its release of approximately 5
million barrels (~680,000 tons) of crude oil into the Gulf of Mexico, is far larger than
any of the individual tanker spills. Given the magnitude of this spill and the scope of
the potential exposures, including the 55,000 workers involved in clean-up efforts and
countless residents of the affected areas, researchers are interested in monitoring Gulf
clean-up workers to understand the adverse consequences of oil spills in general.
- The Gulf Long-term Follow-up Study will investigate health effects associated with the
clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on
April 20, 2010. More than 100,000 persons completed safety training in preparation for
participation in clean-up activities related to the spill. Many of these individuals
participated in active clean-up efforts, but others did not. Exposures among persons
involved in clean-up range from negligible to potentially significant, especially for
workers involved in tasks associated with direct exposure to crude or burning oil, or to
chemical dispersants. However, prediction of adverse health effects is not possible
because the long-term human health consequences of oil spills are largely unknown. In
addition to the oil itself, the widespread economic and lifestyle disruption caused by
the oil spill may contribute to mental health problems among this population.
Objectives:
- To investigate potential short- and long-term health effects associated with clean-up
activities and exposures surrounding the Deepwater Horizon oil spill.
Eligibility:
- English-, Spanish-, and Vietnamese-speaking workers and volunteers at least 21 years of age
engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico, or who
lived in affected areas (Louisiana, Mississippi, Alabama, and Florida coastal regions).
Design:
- Participants will be divided into groups of those who performed oil-spill
clean-up-related work ( exposed ) and those who did not engage in clean-up-related work
( unexposed controls).
- Participants will be screened with a full medical history and physical examination, as
well as an interview to determine the nature of their potential exposure.
- Participants will provide blood, hair, toenail, urine, and saliva (spit) samples.
Participants may also have a lung function exam.
- Participants will have researchers collect dust from their homes by using wipes and
special vacuum bags.
- Participants will also provide detailed contact information, including their Social
Security number, to be contacted in the future for long-term health follow-up
appointments. These appointments will include 30-minute telephone interviews every 2
years....
Description:
The Gulf Long-term Follow-up Study (GuLF STUDY) will investigate potential short- and
long-term health effects associated with the clean-up activities following the Deepwater
Horizon disaster in the Gulf of Mexico on April 20, 2010. Crude oil, burning oil, and the
dispersants used during clean-up efforts contain a range of known and suspected toxins. Over
100,000 persons have completed safety training in preparation for participation in clean-up
activities related to the spill. While many of these individuals participated in active
clean-up efforts, others did not. Exposures among persons involved in clean-up range from
negligible to potentially significant, especially for workers involved in tasks associated
with direct exposure to crude or burning oil, or to chemical dispersants. However, prediction
of adverse health effects is not possible because the long-term human health consequences of
oil spills are largely unknown due to the dearth of research in this area. The potential
health effects associated with the levels of exposure experienced by clean-up workers are
largely unstudied. Heat and stress experienced by these workers may also have adverse
long-term health effects. In addition to the oil itself, the widespread economic and
lifestyle disruption caused by the oil spill may contribute to mental health problems among
this population.
The over-arching hypotheses of this study are:
1. Exposure to constituents of oil, dispersants, and oil-dispersant mixtures, and to
spill-related stress by workers engaged in clean-up of the Deepwater Horizon oil spill
are associated with adverse health effects, particularly respiratory, neurological,
hematologic, and psychological or mental health.
2. There are exposure-response relationships between the above exposures and health
effects.
3. Biomarkers of potentially adverse biologic effects are associated with the above
exposures.
Based on what is known about individuals involved in clean-up efforts, the cohort will
consist primarily of English-, Spanish-, or Vietnamese-speaking adults who performed
oil-spill clean-up-related work ( exposed ) and similar persons who did not engage in
clean-up-related work ( unexposed controls). Accommodations for enrolling participants
speaking other languages will be developed through community collaborations as appropriate.
Workers will be sampled from across job/potential exposure groups. A total of approximately
55,000 persons are expected to be enrolled into the cohort. A random sample of the full
cohort, stratified by category of job/potential exposure (including N~6,000 with no oil-spill
work to serve as controls) and oversampled for workers with higher potential exposures, will
be enrolled into an Active Follow-up Sub-cohort (N~20,000). A random sample of the Active
Follow-up Sub-cohort, also stratified by category of job/potential exposure and oversampled
for workers with higher potential exposures, will be enrolled into a Biomedical Surveillance
Sub-cohort (N~5,000). Participants will be interviewed about their clean-up-related tasks,
demographic and socioeconomic factors, occupational and health histories, psychosocial
factors, and physical and mental health. Members of the Active Follow-up Sub-cohort will also
be asked to provide biological samples (blood, urine, hair, toenail clippings, and possibly
saliva) and environmental samples (house dust) and will have basic clinical measurements
(height, weight, waist and hip circumference, blood pressure, urinary glucose levels, FEV1
and FVC as a measure of pulmonary function) taken during home visits at baseline. The
Biomedical Surveillance Sub-cohort will participate in a more comprehensive clinical
assessment after the initial home visit, including more comprehensive pulmonary function
testing, neurological testing, and collection of additional biological and environmental
samples. The specific tests to be performed and clinical protocols will be developed in
collaboration with extramural investigators selected through a request for proposals (RFP).
When developed, the protocol for this portion of the study will be submitted separately to
the Institutional Review Board as a study amendment.
Exposures will be estimated using detailed job-exposure matrices developed from data from
monitoring performed by different agencies and organizations during the crisis, as well as
information on recommended or actual use of personal protection, information obtained by
interview, and the available scientific literature. It should be noted that, in the absence
of individual or group monitoring data for most workers, estimates of exposure, whether based
on job activities or on more refined job-exposure matrices, will indicate the degree of
potential exposure (i.e., exposure opportunity) rather than known exposure. We will
investigate acute health effects via self-report from the enrollment interview among all
cohort members and also via clinical measures and biological samples from Active Follow-up
Sub-cohort members. All cohort members will be followed for development of a range of health
outcomes through record linkage (cancer, mortality) and if feasible, through linkage with
electronic medical records that may become available during the course of follow-up. Health
outcomes among the Active Follow-up Sub-cohort will also be identified through self-report
via periodic follow-up interviews. Additional outcome information will be obtained on the
Biomedical Surveillance Sub-cohort from periodic follow-up clinical evaluations (e.g.,
spirometry, neurological testing) and analysis of follow-up biospecimens (e.g., immunologic
parameters, liver function, renal function, DNA damage). Follow-up of the entire cohort is
initially planned for 10 years, with extended follow-up possible depending upon scientific
and public health needs and the availability of funds.
Recruitment of subjects should begin in March 2011, with the telephone interviews expected to
be completed within 12-24 months and the baseline home visits within 18-26 months. For the
home visits, we will initially target workers residing in the four most affected Gulf States
(LA, MS, AL, and FL), although we may expand to other states if further information about the
geographic distribution of workers and their potential exposures warrants additional
follow-up in these states. We will work closely with a Community Advisory Board to develop
community support for this study and appropriate communications and study materials.
