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

June 3, 2026 updated by: National Cancer Institute (NCI)

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.

...

Study Overview

Status

Enrolling by invitation

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

64277

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

  • 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 child.
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment over 5 years, ongoing follow-up for life or until study end

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment over 5 years; ongoing follow-up for life or until study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laura E Beane Freeman, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 9, 2026

Primary Completion (Estimated)

December 23, 2027

Study Completion (Estimated)

December 23, 2030

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

January 23, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002253
  • 002253-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe