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Influence of Corn Farming on the Immune System
This study has been completed.
First Received: June 19, 2006   Last Updated: February 19, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00342121
  Purpose

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:

  • Questionnaires and diaries - During the first visit, all participants will have a medical history review, including questions about smoking and other health habits. Farmers will be asked about their farming practices, and controls will be asked about their occupations. Farmers will fill out daily diaries during short time periods of interest around certain pesticide applications to describe farming activities that day. At other times during the growing season before harvest, farmers will fill out weekly diaries describing farming activities; controls, meanwhile, will fill out weekly diaries describing their health and work activities. At home visits during the farmers' growing season, all participants will fill out questionnaires about their health. Finally, farmers and controls will complete a more extensive questionnaire in the off-season, during the last home visit, to learn about their activities and exposures in the final part of the year (post-harvest for farmers).
  • Urine samples: At the time of each home visit, controls will provide a urine sample that the interviewer will take that day. Farmers, too, will provide urine samples at the time of home visits, but they will also collect urine samples for a period of 4 days each during short time periods of interest after certain pesticide applications. The interviewer will collect these samples immediately at the end of these periods.
  • Blood samples: At the time of each home visit, the interviewer will draw 50 ml (3.5 tablespoons) of blood.
  • Telephone calls: Farmers will be called frequently-from once every 2 weeks to every other day-to schedule visits at the times of interest. Control subjects will also be called frequently to schedule their visits closely to those of the farmers.

Condition
Cancer Risk

MedlinePlus related topics: Cancer Lymphoma Pesticides
U.S. FDA Resources
Study Type: Observational
Official Title: Influence of Corn Farming on the Immune System

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

Estimated Enrollment: 40
Study Start Date: May 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342121

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
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

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer
Non-Hodgkin's Lymphoma
Pesticides
Atrazine
Organophosphate Insecticides
Cancer Risk
Normal Control

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009