Prostate CancerNCT00352924
Agriculture Health Study
An observational study of Prostate Cancer and Pesticide Exposures, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Pesticide Exposures, Lymphoma
- How many people
- 89,655 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 1993to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective cohort of 89,655 registered pesticide applicators and spouses (57,310 applicators and 32,346 spouses of private applicators) with sufficient personal identifiers to conduct follow up activities has been assembled during the first four years of recruitment in the Agricultural Health Study, 1993-1997. The majority of applicators were asked to enroll in the AHS as they obtained or renewed their pesticide registration/licenses through the agricultural extension services of the states of North Carolina and Iowa. In the last year of enrollment, applicators who received or renewed their pesticide licenses, but were never given the opportunity to enroll due to added requirements in the testing/training class, were called and asked to complete the enrollment questionnaire over the phone. Spouses of the private applicators were also given the opportunity to enroll via the telephone.
Who may be able to join
- All registered pesticide applicators in Iowa and North Carolina and the spouse and children of applicators who are farmers.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Triangle Institute
Research Triangle Park, North Carolina, 27709
About this study
Official title: The Main Agricultural Health Study - A Prospective Study of Cancer and Other Diseases Among Men and Women in Agriculture
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort.
Initial data collection on a prospective cohort of 89,658 study subjects has been completed as of December 1997. Participants completed questionnaires that included items on pesticides used, other agricultural exposures, and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks (e.g., diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations and smoking history). Phase II of the study (1998-2003) updated information on occupational exposures, diet, work practices and medical history by means of a computer assisted telephone interview. We also collected buccal cells on sample of 34,000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition.
Read more
The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL, multiple myeloma, and prostate) are also increasing in the general population in many of these countries. This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population.
Farmers, their families, and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides, solvents, fuels and oils, engine exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers. The health effects of pesticide use are the primary focus of the study. The influence of other farm exposures are also being evaluated.
The focus of the phase II follow-up period (2004-2008) is to update exposure information and health histories by means of a computer assisted interview and also following the cohort to determine disease incidence and mortality. The cohort is being followed through the cancer registries within Iowa and North Carolina, the Social Security Administration database, state vital statistics offices, National Death Index, and various in-state databases, such as the listing of registered pesticide applicators. Individuals who enrolled into the study but who are no longer at the address given during enrollment (based on subsequent attempts at follow up) have been submitted and will continue to be submitted (through NIOSH) in the standard format to the IRS under their Project 057 Taxpayer Address Request Program. Identifying data provided to the IRS include only SSN and the first four letters of last name of cohort member. IRS provides in return the most current address in IRS records if a match (SSN + all four letter of last name) is found. The purpose of this effort is to identify members of the cohort who have moved out of state, to enable adjustment of person-years for incidence and mortality calculations. Persons who have moved out of state can be followed for vital status and cause of death, but not for cancer incidence.
Continuation of the protocol will provide a valuable epidemiologic resource to help prevent cancers in the future by identifying risk factors in the rural/agricultural environment. Because more cases of important cancer outcomes occur in this cohort every year, potential cancer causes can be evaluated with increased statistical power. Larger number of cases also allows for statistical control of confounding factors, making more meaningful conclusions about cancer risk, and, for some relatively infrequent cancers, such as the lyphomas and leukemias, greater follow-up time is necessary to make any meaningful observations.
Read the detailed description
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort. Initial data collection on a prospective cohort of 89,655 study subjects has been completed as of December 1997. Participants completed questionnaires that included items on pesticides used, other agricultural exposures, and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks (e.g., diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations and smoking history). Phase II of the study (1998-2003) updated information on occupational exposures, diet, work practices and medical history by means of a computer assisted telephone interview. We also collected buccal cells on sample of 34,000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL, multiple myeloma, and prostate) are also increasing in the general population in many of these countries. This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population.
Farmers, their families, and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides, solvents, fuels and oils, engine exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers. The health effects of pesticide use are the primary focus of the study. The influence of other farm exposures are also being evaluated.
- Conditions
- Prostate Cancer, Pesticide Exposures, Lymphoma, Multiple Myeloma
- Keywords
- Cancer, Pesticides, Agriculture, Natural History
- Medical subject headings
- Prostatic Neoplasms, Lymphoma, Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of Agricultural Workers | Cohort of Agricultural Workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-cancer disease incidence in pesticide applicators
Evaluate non-cancer health risks associated with exposure to pesticides and other potential agricultural exposures, e.g., neurotoxicity, reproductive hazards, asthma and other respiratory diseases or symptoms, immunological toxicity, kidney disease, birth outcomes, and growth and development among offspring.
Measured: Follow-up was every 5 years (to date); now to be every 3-5 years (CMS linkage)
measurement of pesticide and other agricultural exposures
Assess agricultural exposures using periodic interviews and environmental and biological monitoring
Measured: Follow-up was every 5 years (to date)
Disease risk and dietary exposures
Identify and quantify cancer and other disease risks associated with dietary exposures and cooking practices and chemicals resulting from the cooking process.
Measured: Baseline and first follow-up only
Disease in spouses and children of farmers
Evaluate the disease risks among spouses and children of farmers that may arise from indirect contact with agricultural chemicals (e.g., ambient air drifts, pesticide residues on rugs, furniture, and other items, transferring chemicals) and nonoccupational exposures (e.g., applications to pets, in homes, and on gardens).
Measured: Cancer as annual; now semi annual; other diseases, about 3-5 years
Cancer incidence in pesticide applicators
Identify and quantify cancer risks among men and women, whites, and minorities associated with specific direct pesticide exposures and exposures to other agricultural agents.
Measured: Was annual; now semi annually (cancer linkages)
Agricultural exposures and biomarkers of exposure, biological effect, and biomarkers of pre-clinical disease and genetic susceptibility factors
Study the relationship between agricultural exposures, the occurrence of biomarkers of exposure, biological effect, and biomarkers of pre-clinical disease and genetic susceptibility factors relevant to carcinogenesis.
Measured: Follow-up was every 5 years (to date); now to be every 3-5 years (CMS linkage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study start30 Apr 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89,655 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- Laura E Beane Freeman, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352924
- Sponsor's protocol ID
- 999993013
- Other IDs
- OH93-NC-N013
- Status last verified
- 6 Oct 2026
- First submitted
- 14 Jul 2006
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alavanja MC, Blair A, Merkle S, Teske J, Eaton B. Mortality among agricultural extension agents. Am J Ind Med. 1988;14(2):167-76. doi: 10.1002/ajim.4700140207.
PubMed 3207102Barthel E. Increased risk of lung cancer in pesticide-exposed male agricultural workers. J Toxicol Environ Health. 1981 Nov-Dec;8(5-6):1027-40. doi: 10.1080/15287398109530135.
PubMed 7338938Bjeldanes LF, Morris MM, Timourian H, Hatch FT. Effects of meat composition and cooking conditions on mutagen formation in fried ground beef. J Agric Food Chem. 1983 Jan-Feb;31(1):18-21. doi: 10.1021/jf00115a005. No abstract available.
PubMed 6826915Lebov JF, Engel LS, Richardson D, Hogan SL, Hoppin JA, Sandler DP. Pesticide use and risk of end-stage renal disease among licensed pesticide applicators in the Agricultural Health Study. Occup Environ Med. 2016 Jan;73(1):3-12. doi: 10.1136/oemed-2014-102615. Epub 2015 Jul 15.
PubMed 26177651
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Main Agricultural Health Study - A Prospective Study of Cancer and Other Diseases Among Men and Women in Agriculture
- ClinicalTrials.gov ID
- NCT00352924
- Acronym / sponsor ID
- 999993013
- Conditions
- Prostate Cancer, Pesticide Exposures, Lymphoma, Multiple Myeloma
- Keywords
- Cancer, Pesticides, Agriculture, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 89,655 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Environmental Protection Agency (EPA)
- Study start
- 30 Apr 1993
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort.
Initial data collection on a prospective cohort of 89,658 study subjects has been completed as of December 1997. Participants completed questionnaires that included items on pesticides used, other agricultural exposures, and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks (e.g., diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations and smoking history). Phase II of the study (1998-2003) updated information on occupational exposures, diet, work practices and medical history by means of a computer assisted telephone interview. We also collected buccal cells on sample of 34,000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition.
The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL, multiple myeloma, and prostate) are also increasing in the general population in many of these countries. This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population.
Farmers, their families, and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides, solvents, fuels and oils, engine exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers. The health effects of pesticide use are the primary focus of the study. The influence of other farm exposures are also being evaluated.
The focus of the phase II follow-up period (2004-2008) is to update exposure information and health histories by means of a computer assisted interview and also following the cohort to determine disease incidence and mortality. The cohort is being followed through the cancer registries within Iowa and North Carolina, the Social Security Administration database, state vital statistics offices, National Death Index, and various in-state databases, such as the listing of registered pesticide applicators. Individuals who enrolled into the study but who are no longer at the address given during enrollment (based on subsequent attempts at follow up) have been submitted and will continue to be submitted (through NIOSH) in the standard format to the IRS under their Project 057 Taxpayer Address Request Program. Identifying data provided to the IRS include only SSN and the first four letters of last name of cohort member. IRS provides in return the most current address in IRS records if a match (SSN + all four letter of last name) is found. The purpose of this effort is to identify members of the cohort who have moved out of state, to enable adjustment of person-years for incidence and mortality calculations. Persons who have moved out of state can be followed for vital status and cause of death, but not for cancer incidence.
Continuation of the protocol will provide a valuable epidemiologic resource to help prevent cancers in the future by identifying risk factors in the rural/agricultural environment. Because more cases of important cancer outcomes occur in this cohort every year, potential cancer causes can be evaluated with increased statistical power. Larger number of cases also allows for statistical control of confounding factors, making more meaningful conclusions about cancer risk, and, for some relatively infrequent cancers, such as the lyphomas and leukemias, greater follow-up time is necessary to make any meaningful observations.
Detailed description
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort. Initial data collection on a prospective cohort of 89,655 study subjects has been completed as of December 1997. Participants completed questionnaires that included items on pesticides used, other agricultural exposures, and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks (e.g., diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations and smoking history). Phase II of the study (1998-2003) updated information on occupational exposures, diet, work practices and medical history by means of a computer assisted telephone interview. We also collected buccal cells on sample of 34,000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL, multiple myeloma, and prostate) are also increasing in the general population in many of these countries. This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population.
Farmers, their families, and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides, solvents, fuels and oils, engine exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers. The health effects of pesticide use are the primary focus of the study. The influence of other farm exposures are also being evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of Agricultural Workers | – | –Cohort of Agricultural Workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort of 89,655 registered pesticide applicators and spouses (57,310 applicators and 32,346 spouses of private applicators) with sufficient personal identifiers to conduct follow up activities has been assembled during the first four years of recruitment in the Agricultural Health Study, 1993-1997. The majority of applicators were asked to enroll in the AHS as they obtained or renewed their pesticide registration/licenses through the agricultural extension services of the states of North Carolina and Iowa. In the last year of enrollment, applicators who received or renewed their pesticide licenses, but were never given the opportunity to enroll due to added requirements in the testing/training class, were called and asked to complete the enrollment questionnaire over the phone. Spouses of the private applicators were also given the opportunity to enroll via the telephone.
Key inclusion criteria (1 listed)
- All registered pesticide applicators in Iowa and North Carolina and the spouse and children of applicators who are farmers.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-cancer disease incidence in pesticide applicators
Time frame: Follow-up was every 5 years (to date); now to be every 3-5 years (CMS linkage)
Evaluate non-cancer health risks associated with exposure to pesticides and other potential agricultural exposures, e.g., neurotoxicity, reproductive hazards, asthma and other respiratory diseases or symptoms, immunological toxicity, kidney disease, birth outcomes, and growth and development among offspring.
measurement of pesticide and other agricultural exposures
Time frame: Follow-up was every 5 years (to date)
Assess agricultural exposures using periodic interviews and environmental and biological monitoring
Disease risk and dietary exposures
Time frame: Baseline and first follow-up only
Identify and quantify cancer and other disease risks associated with dietary exposures and cooking practices and chemicals resulting from the cooking process.
Disease in spouses and children of farmers
Time frame: Cancer as annual; now semi annual; other diseases, about 3-5 years
Evaluate the disease risks among spouses and children of farmers that may arise from indirect contact with agricultural chemicals (e.g., ambient air drifts, pesticide residues on rugs, furniture, and other items, transferring chemicals) and nonoccupational exposures (e.g., applications to pets, in homes, and on gardens).
Cancer incidence in pesticide applicators
Time frame: Was annual; now semi annually (cancer linkages)
Identify and quantify cancer risks among men and women, whites, and minorities associated with specific direct pesticide exposures and exposures to other agricultural agents.
Agricultural exposures and biomarkers of exposure, biological effect, and biomarkers of pre-clinical disease and genetic susceptibility factors
Time frame: Follow-up was every 5 years (to date); now to be every 3-5 years (CMS linkage)
Study the relationship between agricultural exposures, the occurrence of biomarkers of exposure, biological effect, and biomarkers of pre-clinical disease and genetic susceptibility factors relevant to carcinogenesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 3207102Alavanja MC, Blair A, Merkle S, Teske J, Eaton B. Mortality among agricultural extension agents. Am J Ind Med. 1988;14(2):167-76. doi: 10.1002/ajim.4700140207.
- Background: PubMed 7338938Barthel E. Increased risk of lung cancer in pesticide-exposed male agricultural workers. J Toxicol Environ Health. 1981 Nov-Dec;8(5-6):1027-40. doi: 10.1080/15287398109530135.
- Background: PubMed 6826915Bjeldanes LF, Morris MM, Timourian H, Hatch FT. Effects of meat composition and cooking conditions on mutagen formation in fried ground beef. J Agric Food Chem. 1983 Jan-Feb;31(1):18-21. doi: 10.1021/jf00115a005. No abstract available.
- Derived from this study: PubMed 26177651Lebov JF, Engel LS, Richardson D, Hogan SL, Hoppin JA, Sandler DP. Pesticide use and risk of end-stage renal disease among licensed pesticide applicators in the Agricultural Health Study. Occup Environ Med. 2016 Jan;73(1):3-12. doi: 10.1136/oemed-2014-102615. Epub 2015 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura E Beane Freeman, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Pesticide Exposures, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-cancer disease incidence in pesticide applicators (time frame: Follow-up was every 5 years (to date); now to be every 3-5 years (CMS linkage)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00352924, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.