NHLNCT00342121
Influence of Corn Farming on the Immune System
An observational study of NHL, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- NHL
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2002to 5 Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.@@@
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
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 (e.g., 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 (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.
- Conditions
- NHL
- Keywords
- Cancer, NHL, Pesticides, Atrazine, Organophosphates, Cancer Risk, Normal Control
- Medical subject headings
- 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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after application of pesticies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 May 2002
- Primary completion31 Jan 2004
- Study completion5 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura Beane-Freeman, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342121
- Sponsor's protocol ID
- 999902197
- Other IDs
- 02-C-N197
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2006
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corn Farming on the Immune System
- ClinicalTrials.gov ID
- NCT00342121
- Acronym / sponsor ID
- 999902197
- Conditions
- NHL
- Keywords
- Cancer, NHL, Pesticides, Atrazine, Organophosphates, Cancer Risk, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 May 2002
- Primary completion
- 31 Jan 2004 (actual)
- Study completion
- 5 Feb 2008 (actual)
- First posted
- 21 Jun 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.
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.
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.
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 (e.g., 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 (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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.@@@
Key inclusion criteria (4 listed)
- 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.
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
Immunilogical effects of farming exposues
Time frame: Before and after application of pesticies
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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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 Beane-Freeman 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 NHL, 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 4 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: finished, as of the sponsor's last update on 10 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunilogical effects of farming exposues (time frame: Before and after application of pesticies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2020.