Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342121
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2006-06-19
Brief Title:
Influence of Corn Farming on the Immune System
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Influence of Corn Farming on the Immune System
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 35 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
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 35 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
Detailed Description:
When compared to the general population farmers have an increased risk of non-Hodgkins lymphoma NHL and certain other hematopoeitic cancers ie 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 ie 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
This protocol outlines a study of immune effects among corn farmers within Agricultural Health Study AHS cohort The main objective 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 were 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 allowed examination of short-term biologic effects associated with specific pesticide exposures and general planting activities eg tillage The first post-emergent application of organophosphate insecticide will also be monitored in order to evaluate short-term biologic effects associated with this OP exposture Post-harvest and off-season samples also were collected to allow evaluation of overall immune effects of farming activities Pesticide exposures eg atrazine OPs and potentially 24-D or carbamates are being 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 serve as their own self-controls and a selected control group will provide a means for external comparison
This protocol outlines a study of immune effects among corn farmers within Agricultural Health Study AHS cohort The main objective 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 were 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 allowed examination of short-term biologic effects associated with specific pesticide exposures and general planting activities eg tillage The first post-emergent application of organophosphate insecticide will also be monitored in order to evaluate short-term biologic effects associated with this OP exposture Post-harvest and off-season samples also were collected to allow evaluation of overall immune effects of farming activities Pesticide exposures eg atrazine OPs and potentially 24-D or carbamates are being 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 serve as their own self-controls and a selected control group will provide a means for external comparison
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N197 | None | None | None |