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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07328516
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Study Details

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. ...

Key Dates

Start date
Jun 16, 2026
Status verified
Jan 2026
Primary completion
Dec 23, 2027
Completion
Dec 23, 2030

Study Design

Enrollment
64,277 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Incidence of Cancer [ Time Frame: Enrollment over 5 years, ongoing follow-up for life or until study end ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Cancer Institute (NCI)BethesdaMaryland20892-

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