Gulf Long-Term Follow-Up Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01287000
First received: January 25, 2011
Last updated: August 2, 2014
Last verified: July 2014
  Purpose

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.

Condition
Cardiovascular Disease
Hematologic Diseases
Immunologic Disease
Cancer
Respiratory Function

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gulf Long-Term Follow-Up Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To investigate potential short- and long-term health effects associated with oil spill clean-up activities/exposures surrounding the Deepwater Horizon Disaster.

Secondary Outcome Measures:
  • To investigate biomarkers of potentially adverse biological effect in relation to oil spill clean-up activities/exposures.
  • To create a resource for additional collaborative research on focused hypotheses or subgroups.
  • To create a resource to better understand the short and long-term human health effects of oil and oil dispersants in the environment.

Estimated Enrollment: 55000
Study Start Date: January 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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:

  • 21 years of age or older
  • Fall into one of two oil-related exposure categories:

    • Potentially exposed subjects must have completed at least one day of oil-spill clean-up-related work (other than safety training), either paid or volunteer.
    • Unexposed subjects will be individuals who were not directly involved in oil spill clean-up activities, but who worked near the oil spill or completed some oil spill worker training.
  • Unexposed subjects will be individuals who were not directly involved in oil spill clean-up activities, but who worked near the oil spill or completed some oil spill worker training.
  • pregnant women will be allowed to enroll in the study, and women who become pregnant during the study will not be withdrawn.

EXCLUSION CRITERIA:

  • Children will not be enrolled because they were not allowed to participate in clean-up activities.
  • Those who were deemed medically ineligible to participate in clean-up activities because of pre-existing conditions are excluded because they won t be representative of those individuals who were engaged in clean-up activities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287000

Contacts
Contact: Dale Sandler, Ph.D. (919) 541-4668 sandler@niehs.nih.gov

Locations
United States, North Carolina
NIEHS, Research Triangle Park Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Dale Sandler, Ph.D.    919-541-4668    sandler@niehs.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Dale Sandler, Ph.D. National Institute of Environmental Health Sciences (NIEHS)