NCT07328516

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 64,277 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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. ...

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.

Conditions

• Prostate Cancer
• Leukemia
• Breast Cancer
• Melanoma
• Colorectal Cancer

Timeline

• Start date: 2026-04-22
• Primary completion: 2027-12-23
• Completion: 2030-12-23
• First posted: 2026-01-09
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States