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By invitationNCT07328516ClinicalTrials.gov record

Natural History Study of Early Life Exposures in Agriculture (ELEA)

Prostate Cancer · Leukemia · Breast Cancer · Melanoma · Colorectal Cancer

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - 99 years
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
64277 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Study Description:

ELEA is an observational cohort study that will collect exposure information and biospecimens from the adult children of the Agricultural Health Study (AHS) cohort (https://aghealth.nih.gov/about; Protocol OH93NCN013).

The primary hypothesis is that early life exposures, particularly those found in the agricultural environment, are associated with cancer and other adverse health outcomes in childhood and early adulthood. Eligible individuals will be invited to complete an online questionnaire. After enrollment, study participants may be asked to donate biological and environmental samples. Participants will be followed for cancer and other disease endpoints. Data will be collected from North Carolina and Iowa health registries, disease specific databases, the National Death Index (NDI), North Carolina and Iowa state health registries, publicly available environmental datasets, discarded sample repository, and collection of available samples. Investigators will access data and biospecimens from the AHS protocol OH93NCN01 and link it to the ELEA population.

In an earlier ELEA protocol (16CN095) the NCI SS IRB approved the protocol to perform linkages. That protocol was closed after the transition to the NIH IRB (per a NHSR determination), but the linkage work continued under the ELEA protocols that remained open with Westat and Iowa.

Objectives:

Primary:

To investigate the effect of specific pesticides and other agricultural exposures and risk of cancer in children and adults.

Secondary:

To investigate the effect of non-agricultural exposures and the risk of cancer and other diseases in children and adults.

Exploratory:

Exploratory objectives include, but are not limited to, the examination of genetic and various molecular biomarkers in relation to childhood agricultural exposures.

Endpoints:

Primary:

Incidence of Cancer

Secondary:

Incidence of diseases other than cancer, survival, and various molecular biomarkers.

...

Read the full description

Study Description:

ELEA is an observational cohort study that will collect exposure information and biospecimens from the adult children of the Agricultural Health Study (AHS) cohort (https://aghealth.nih.gov/about; Protocol OH93NCN013).

The primary hypothesis is that early life exposures, particularly those found in the agricultural environment, are associated with cancer and other adverse health outcomes in childhood and early adulthood. Eligible individuals will be invited to complete an online questionnaire. After enrollment, study participants may be asked to donate biological and environmental samples. Participants will be followed for cancer and other disease endpoints. Data will be collected from North Carolina and Iowa health registries, disease specific databases, the National Death Index (NDI), North Carolina and Iowa state health registries, publicly available environmental datasets, discarded sample repository, and collection of available samples. Investigators will access data and biospecimens from the AHS protocol OH93NCN01 and link it to the ELEA population.

In an earlier ELEA protocol (16CN095) the NCI SS IRB approved the protocol to perform linkages. That protocol was closed after the transition to the NIH IRB (per a NHSR determination), but the linkage work continued under the ELEA protocols that remained open with Westat and Iowa.

Objectives:

Primary:

To investigate the effect of specific pesticides and other agricultural exposures and risk of cancer in children and adults.

Secondary:

To investigate the effect of non-agricultural exposures and the risk of cancer and other diseases in children and adults.

Exploratory:

Exploratory objectives include, but are not limited to, the examination of genetic and various molecular biomarkers in relation to childhood agricultural exposures.

Endpoints:

Primary:

Incidence of Cancer

Secondary:

Incidence of diseases other than cancer, survival, and various molecular biomarkers.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male or female, aged 18 years old and older.
2. Children (biological or adopted) of an AHS participant ( The Main Agricultural Health Study - A Prospective Study of Cancer and Other Diseases among Men and Women in Agriculture (OH93NCN013)).
3. Spent time on a farm as a childhood or otherwise had agricultural exposures as a child (e.g., lived on a farm regularly; visited a farm; helped with farm work; or was exposed to farm chemicals, dust, or other farm-related materials).
4. Ability to understand the written consent information sheet and agree to participate.

EXCLUSION CRITERIA:

There are no exclusionary criteria other than inability to meet the eligibility criteria.

Study population

The study population will be drawn from individuals who meet the following eligibility criteria: males and females, including pregnant women, who are 18 years of age or older; biological or adopted children of a participant in "The Main Agricultural Health Study - A Prospective Study of Cancer and Other Diseases among Men and Women in Agriculture (OH93NCN013)"; individuals who spent time on a farm during their childhood; and those who are able to understand the written consent information sheet and agree to participate in the study.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Biological and Adopted Children of parents was formerly in the AHS study

This group consists of individuals who are either biological or adopted children of participants from the original Agricultural Health Study, allowing for examination of intergenerational effects and genetic versus environmental influences.

Male and Women

This group includes all adult participants, both men and women, reflecting a gender-inclusive cohort that allows for analysis of sex-specific health outcomes and differences.

Participants who can read and understand consent form

This group includes individuals who are able to comprehend and agree to the study's written consent materials, ensuring informed participation and ethical standards are met.

Participants who spent time on a farm

This criterion ensures all participants had direct exposure to farm environments during their childhood, providing a basis for studying the impact of early agricultural exposures on long-term health.

Pregnant Women

Pregnant women are specifically included to ensure that the study can assess health outcomes and potential risks associated with pregnancy in individuals with a background of agricultural exposure.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Incidence of Cancer

Time frame: Enrollment over 5 years, ongoing follow-up for life or until study end

To investigate the effect of specific pesticides and other agricultural exposures on the risk of cancer in children and adults. Participants will complete an online questionnaire (45 60 minutes), provide biological samples, and be monitored for cancer development throughout long-term follow-up.

Secondary measures

Incidence of diseases other than cancer, survival, and various molecular biomarkers

Time frame: Enrollment over 5 years; ongoing follow-up for life or until study end

To assess the effect of non-agricultural exposures on the risk of cancer and other diseases in children and adults. The study will also track survival and collect molecular biomarker data to better understand additional health outcomes beyond cancer.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

National Cancer Institute (NCI)Bethesda, Maryland, United StatesStatus unknown

Study team and timeline

Lead sponsor
National Cancer Institute (NCI)
Study start
Nov 15, 2026 Estimated
Primary completion
Dec 23, 2027 Estimated
Study completion
Dec 23, 2030 Estimated
First posted
Jan 9, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Natural History Study of Early Life Exposures in Agriculture (ELEA)

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026