Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study
NCT ID: NCT01139476
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1892 participants
OBSERVATIONAL
2010-06-15
Brief Summary
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\- 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.
* During the home visit, a study researcher will take blood samples and collect the urine sample, and will administer another questionnaire.
* Participants in the group exposed to diazinon will have three home visits for the study: (1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and (3) about 21 days after the second visit. The first visit will take place in the off-season from January to March; the second and third visits will be conducted between April and August.
* No treatment will be provided as part of this study.
Detailed Description
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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 evaluate the biological plausibility and the mechanism-of-action of associations between pesticides and cancers observed in earlier AHS studies. Many of these pesticides are non-genotoxic and their mechanism of carcinogenesis has not been determined. One such future study involving repository samples will be an investigation of monoclonal B-cell lymphocytosis (MBL), a marker which has been shown to precede chronic lymphocytic leukemia in previous studies. Several pesticides in current widespread use in the AHS have been linked to leukemia. We will determine the prevalence of MBL in the AHS cohort and evaluate potential associations with specific pesticides of interest to better explain the relation between pesticide exposures and leukemia risk.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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AHS BEEA participants
A subset of 1990 AHS cohort members who are male private pesticide applicators, living and over 50 years of age at the time contact, cancer free, and who completed AHS Phases IIII.
No interventions assigned to this group
Non-AHS BEEA participants
A group of 225 age-, race-, and countymatched, non-AHS controls, who have not lived or worked on a farm as an adult, or held a job applying pesticides.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Male private pesticide applicator;
2. Alive as of the latest update of the National Death Index G\\fDD and over 50 years of age at the time of initial contact:
3. Cancer free as of the most recent linkage with the appropriateCancer Registry;
4. Completed phase I, II and III interviews (these study subjects have the most comprehensive exposure evaluation and also will be the most interested in the study).
Exclusion Criteria
2. Ever diagnosed with any type of cancer other than non-melanoma skin cancer;
3. Unable to speak English;
4. Have a blood clotting disorder such as hemophilia; or
5. Registered with the AHS as a "no contact".
18 Years
100 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jonathan N Hofmann, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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University of Iowa
Iowa City, Iowa, United States
Countries
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Other Identifiers
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10-C-N106
Identifier Type: -
Identifier Source: secondary_id
999910106
Identifier Type: -
Identifier Source: org_study_id