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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00342121 |
This study will look for links between corn farming practices and short-term changes in immune function in farmers throughout the growing season. It will examine biologic effects associated with specific pesticide exposures and general planting activities, such as tillage. Farmers have an increased risk of non-Hodgkin's lymphoma and certain other blood cancers such as multiple myeloma and leukemia, but the reasons for this increase have not been identified.
Findings of this study may contribute to learning the causes of cancers such as non-Hodgkin's lymphoma.
Farmers enrolled in the Agricultural Health Study (a study of pesticide applicators and their spouses in Iowa and North Carolina) and a group of control subjects selected from agricultural extension workers in Iowa may participate in this study.
The study involves six home visits to farmers and four visits to farmers to individuals in the control group. All participants will complete the following tests and procedures:
Condition |
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Cancer Risk |
Study Type: | Observational |
Official Title: | Influence of Corn Farming on the Immune System |
Estimated Enrollment: | 40 |
Study Start Date: | May 2002 |
When compared to the general population, farmers have an increased risk of non-Hodgkin's lymphoma (NHL) and certain other hematopoeitic cancers (i.e., multiple myeloma, leukemia). Factors that contribute to this excess risk have not been discerned. While several epidemiologic studies have observed an increased risk of NHL among farmers who are exposed to certain pesticides (i.e., phenoxyacetic acids, organophosphates, organochlorines, and triazines), these studies have not been conclusive. In addition, a clear mechanistic association between farming or pesticide exposure and subsequent development of cancer has not been identified. Given that immunocompromised individuals are at increased risk for NHL, it has been hypothesized that altered immune function may be an indicator of increased potential for the development of immunologically based diseases such as NHL. Therefore, research into early immunologic effects of farming exposures holds some promise in discerning disease mechanisms and in identifying specific etiologic agents for lymphatic cancers such as NHL. Few such studies have been conducted.
The main objective of this study is to evaluate the changes in immune parameters in farmers throughout the growing season, as well as effects of specific pesticide exposures including atrazine and organophosphate (OP) insecticides. Farmers and control subjects will be contacted just prior to planting (February-March) to be enrolled in the study. Biological sampling before and after planting and application of preemergent pesticides (likely to include atrazine and possibly Ops or carbamates) will allow examination of short-term biologic effects associated with specific pesticide exposures and general planting activities (e.g., tillage). Post-harvest and off-season samples will also be collected to allow evaluation of overall immune effects of farming activities. Pesticide exposures (e.g., atrazine, OPs, and potentially 2,4-D or carbamates) will be assessed primarily by measurement of the parent compound or its metabolites in urine, and additional information on farming activities and work practices will be obtained by questionnaire. Farmers will serve as their own self-controls, and a selected control group will provide a means for external comparison.
Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Male corm farmers in the AHS who plan to apply specific pesticides.
Any ethnicity or race groups are included.
Limit the age criteria for inclusion to 40 to 60 years.
Only non-smokers are included in the study.
Study ID Numbers: | 999902197, 02-C-N197 |
Study First Received: | June 19, 2006 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00342121 History of Changes |
Health Authority: | United States: Federal Government |
Cancer Non-Hodgkin's Lymphoma Pesticides Atrazine |
Organophosphate Insecticides Cancer Risk Normal Control |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma |