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

Last updated: April 2, 2026
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Enrolling

Phase

N/A

Condition

Melanoma

Breast Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT07328516
10002253
002253-C
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

...

Eligibility Criteria

Inclusion

  • 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 AgriculturalHealth Study - A Prospective Study of Cancer and Other Diseases among Men and Womenin Agriculture (OH93NCN013)).

  3. Spent time on a farm as a child.

  4. Ability to understand the written consent information sheet and agree toparticipate.

Exclusion

EXCLUSION CRITERIA:

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

Study Design

Total Participants: 64277
Study Start date:
April 08, 2026
Estimated Completion Date:
December 23, 2030

Study 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.

Connect with a study center

  • National Cancer Institute (NCI)

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • National Cancer Institute (NCI)

    Bethesda 4348599, Maryland 4361885 20892
    United States

    Site Not Available

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