NCT00342121

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2008

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

June 19, 2006

Last Update Submit

September 8, 2020

Conditions

Keywords

CancerNHLPesticidesAtrazineOrganophosphatesCancer RiskNormal Control

Outcome Measures

Primary Outcomes (1)

  • Immunilogical effects of farming exposues

    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. Pesticide exposures (e.g., atrazine, OPs, and potentially 2,4-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.

    Before and after application of pesticies

Study Arms (2)

1

Corn farmers enrolled in the Agricultural Health Study who are non-smokers, and who plan to apply specific pesticides.

2

Control subjects selected from agricultural extension workers in Iowa who are non-smokers

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Farmers enrolled in the Agricultural Health Study and a group of control subjects selected from agricultural extension workers in Iowa may participate in this study. Specifically, male corm farmers in the AHS who plan to apply specific pesticides. Only non-smokers are included in the study.@@@

You may qualify if:

  • Male corm farmers in the AHS who plan to apply specific pesticides.
  • Any ethnicity or race groups are included.
  • Only non-smokers are included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Laura Beane-Freeman

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 3, 2002

Primary Completion

January 31, 2004

Study Completion

February 5, 2008

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations