Gulf Long-Term Follow-Up Study
|First Received Date ICMJE||January 25, 2011|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||January 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To investigate potential short- and long-term health effects associated with oil spill clean-up activities/exposures surrounding the Deepwater Horizon Disaster.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01287000 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To investigate biomarkers of potentially adverse biological effect in relation to oil spill clean-up activities/exposures.Outcome:To create a resource for additional collaborative research on focused hypotheses or subgroups.To ...|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gulf Long-Term Follow-Up Study|
|Official Title ICMJE||Gulf Long-Term Follow-Up Study|
- To investigate potential short- and long-term health effects associated with clean-up activities and exposures surrounding the Deepwater Horizon oil spill.
- 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).
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:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||55000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
We anticipate screening as many as 90,000 individuals in order to recruit approximately 55,000 volunteers primarily from the four most affected Gulf States* (LA, MS, AL, and FL) into the cohort, which will include a randomly sampled Active Follow-up Sub-cohort of approximately 24,000 individuals nested within it. Eligibility criteria for the cohort include:
|Ages||21 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01287000|
|Other Study ID Numbers ICMJE||999911076, 11-E-N076|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Environmental Health Sciences (NIEHS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2013|
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