- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743481
Early Life Exposures in Agriculture
Background:
The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes.
Objective:
To study data to find links between early life farm exposure and negative health outcomes.
Eligibility:
There will be no human subjects.
Design:
Researchers will get public data in the two study states. This will come from things like:
Birth certificates
Driver s licenses
Voter registration
Death certificates
Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA).
Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.
They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides.
Researchers will analyze the cancer and pesticide results and look for links.
Study Overview
Status
Conditions
Detailed Description
There is increasing evidence that early life exposures may influence future health outcomes although there is a critical need to more fully understand how these may differ from exposures received later in life. The farm environment includes pesticides that have been suggested to increase cancer risk in both children and adults. A review of the literature identified crucial gaps in our knowledge and highlighted the need for accurate exposure assessment, including separate parental interviews, specific pesticide exposure questions, and semiquantitative exposure measures that can be used to confirm information obtained through questionnaires 2. Some studies suggest that the timing of exposure may be particularly important. For example, in a study of the insecticide DDT and breast cancer, researchers observed the highest risks among women exposed prior to age 14 compared to later in life 3. The agricultural environment also includes other exposures such as animals, allergens, and endotoxins. These exposures may influence immune function, particularly when exposed at a young age, and subsequently affect later cancer risk.
The Agricultural Health Study (AHS) is a prospective cohort study of farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa. At enrollment (1993-7) women (farmers and spouses of farmers) provided information on their children born since 1975, including name, gender, SSN and dates of birth. In previous analyses conducted using Iowa AHS data only for cancer incidence and all-cause mortality in children under the age of 19, findings suggested increased risks of incident cancer among these children associated with the use of certain pesticides by their parents. The mortality analysis focused on fatal injuries sustained, indicative of the dangerous nature of working on the farm6. In collaboration with researchers at the University of Iowa, we are currently updating the previous analysis with new cancer incidence information through 2011 and information provided by the University of Iowa, which has performed a linkage to Iowa birth certificates to identify additional children born to AHS participants from 1975-2009.
With this proposal, we are proposing to further expand the linkages in Iowa to include children not previously included, and to link to the North Carolina registries for the first time to identify additional 2 births, cancer incidence and mortality. This will establish a unique cohort of agriculturally exposed offspring, with comprehensive information on their parents farming practices, as well as other information. These data will be used to evaluate the hypothesis that early life agricultural exposures influence cancer risk. Previous analyses have only focused on childhood cancers; we will include cancers diagnosed from birth through adulthood.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- children born to Agricultural Health Study (AHS) participants from 1975-2009.
- individuals identified through questionnaire or through the probabilistic and deterministic match to the birth registries as being the offspring of the AHS participants.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer incidence
Time Frame: Birth through 2014
|
Cancer incidence
|
Birth through 2014
|
Mortality
Time Frame: Birth through 2014
|
Death
|
Birth through 2014
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Testicular Neoplasms
- Brain Neoplasms
Other Study ID Numbers
- 999916095
- 16-C-N095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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