Gulf Long-Term Follow-Up Study

NCT01287000 | Active Not Recruiting

• 2 other identifiers: 99991107611-E-N076
• Study Type: observational
• Target: 32,658
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Diseases; Cardiovascular Disease; Immunologic Disease; Cancer; Respiratory Function

Keywords

Respiratory Health Outcomes; Mental Health; Dispersant(s); Oil Spill; Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

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

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

  Ongoing

Secondary Outcomes (1)

• To investigate biomarkers of potentially adverse biological effect in relation to oil spill clean-up activities/exposures.

  Ongoing

Study Arms (1)

1

Workers and volunteers engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Workers and volunteers engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Social & Scientific Systems

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hematologic Diseases; Immune System Diseases; Neoplasms; Respiratory Aspiration; Psychological Well-Being

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Dale P Sandler, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 1, 2011
• Study Start: March 24, 2011
• Last Updated: May 5, 2026

Record last verified: 2025-12-08

Locations

US (1)