Clinical Trial: Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Study of Biomarkers of Exposure and Effects in Agriculture

Brief Summary:

Background:

- Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often preceded by a precancerous disorder known as monoclonal gammopathy of undetermined significance (MGUS). Farmers and other agricultural workers have a higher risk of developing MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are interested in studying biological specimens taken from participants in the Agricultural Health Study specifically, pesticide applicators at least 50 years of age who do not have cancer to better understand the development of MGUS and MM.

Objectives:

  • To collect biological specimens from Agricultural Health Study participants for further research.
  • To examine the relationship between pesticide exposure and MGUS/MM.

Eligibility:

- Male pesticide applicators who are over 50 years of age, cancer-free, and participating in the Agricultural Health Study.

Design:

  • Two groups of participants will complete the study: a general group and a smaller group of individuals who have been exposed to the pesticide diazinon.
  • All participants will receive an initial contact letter with information about the study, followed by a phone call to administer a screening questionnaire and arrange a home visit from a researcher within the next month.
  • Participants will receive by mail a urine specimen kit that will be collected at the home visit.

  • Detailed Summary:

    We propose to conduct a molecular epidemiology study with a subset of participants in the Agricultural Health Study (AHS), a prospective cohort of 57,310 licensed pesticide applicators in Iowa and North Carolina. Blood and urine samples will be collected from 2,200 cancer-free male AHS participants over the age of 50. These participants will also be asked to complete a brief interview (approximately 20 minutes) regarding recent exposures and other lifestyle and health characteristics, which will be conducted at the time of the biospecimen collection. Participants in both Iowa and North Carolina will be enrolled and home visits for interviews and sample collection will take place throughout the year between 2010-2014.

    The proposed study has two primary objectives. First, we will determine the prevalence and study the etiology of monoclonal gammopathy of undetermined significance (MGUS), which is a precursor biomarker for multiple myeloma. We will compare the prevalence of MGUS in the AHS cohort with the prevalence in two general population-based cohorts ( i.e., Olmsted County and NHANES IID) with well-characterized MGUS prevalence levels. As a result of previous data collection efforts in the AHS, comprehensive information on lifetime occupational exposures and lifestyle factors will be available for the subjects included in this study. We will examine the associations between MGUS and lifetime exposure to specific pesticides within the AHS cohort. We will also evaluate several other biomarkers, including telomere length and global DNA hypomethylation in peripheral blood lymphocytes, for associations with specific pesticides and excess risk of MGUS.

    The second objective is to establish a resource with the remaining blood and urine samples collected from the participants in this study. These biospecimens will be used to eval
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome: No intervention; looking for associations between MGUS and specific pesticides within the AHS cohort and whether selected biomarkers are associated with excess MGUS [ Time Frame: Most participants receive specimen collection at one time-point (home visit); selected participants receive specimen collection at three time-points (home-visit) ]

    Original Primary Outcome:

    Current Secondary Outcome: Establish a resource with the remaining biospecimens collected from the participants of the MGUS study that will be used to evaluate the biological plausibility and the mechanism-of-action of associations between pesticides and cancers in earlie...

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: June 5, 2010
    Date Started: May 11, 2010
    Date Completion:
    Last Updated: April 21, 2017
    Last Verified: January 26, 2017