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

NCT07328516 | Enrolling By Invitation

• 2 other identifiers: 10002253002253-C
• Study Type: observational
• Target: 64,277
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Prostate Cancer; Leukemia; Breast Cancer; Melanoma; Colorectal Cancer

Keywords

Agricultural Health Study; Carolina; National Cancer Institute; Iowa; non-agricultural exposures; Children; Adults; ELEA; National Program of Cancer Registries; Environmental

Outcome Measures

Primary Outcomes (1)

• Incidence of Cancer

  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 Outcomes (1)

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

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

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, aged 18 years old and older.
• 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)).
• Spent time on a farm as a child.
• Ability to understand the written consent information sheet and agree to participate.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (7)

• Metayer C, Colt JS, Buffler PA, Reed HD, Selvin S, Crouse V, Ward MH. Exposure to herbicides in house dust and risk of childhood acute lymphoblastic leukemia. J Expo Sci Environ Epidemiol. 2013 Jul;23(4):363-70. doi: 10.1038/jes.2012.115. Epub 2013 Jan 16.

  PMID: 23321862 BACKGROUND

• Patel DM, Jones RR, Booth BJ, Olsson AC, Kromhout H, Straif K, Vermeulen R, Tikellis G, Paltiel O, Golding J, Northstone K, Stoltenberg C, Haberg SE, Schuz J, Friesen MC, Ponsonby AL, Lemeshow S, Linet MS, Magnus P, Olsen J, Olsen SF, Dwyer T, Stayner LT, Ward MH; International Childhood Cancer Cohort Consortium. Parental occupational exposure to pesticides, animals and organic dust and risk of childhood leukemia and central nervous system tumors: Findings from the International Childhood Cancer Cohort Consortium (I4C). Int J Cancer. 2020 Feb 15;146(4):943-952. doi: 10.1002/ijc.32388. Epub 2019 May 24.

  PMID: 31054169 BACKGROUND

• Flower KB, Hoppin JA, Lynch CF, Blair A, Knott C, Shore DL, Sandler DP. Cancer risk and parental pesticide application in children of Agricultural Health Study participants. Environ Health Perspect. 2004 Apr;112(5):631-5. doi: 10.1289/ehp.6586.

  PMID: 15064173 BACKGROUND

• von Mutius E, Radon K. Living on a farm: impact on asthma induction and clinical course. Immunol Allergy Clin North Am. 2008 Aug;28(3):631-47, ix-x. doi: 10.1016/j.iac.2008.03.010.

  PMID: 18572111 BACKGROUND

• Carnes MU, Hoppin JA, Metwali N, Wyss AB, Hankinson JL, O'Connell EL, Richards M, Long S, Freeman LE, Sandler DP, Henneberger PK, Barker-Cummings C, Umbach DM, Thorne PS, London SJ. House Dust Endotoxin Levels Are Associated with Adult Asthma in a U.S. Farming Population. Ann Am Thorac Soc. 2017 Mar;14(3):324-331. doi: 10.1513/AnnalsATS.201611-861OC.

  PMID: 27977294 BACKGROUND

• Erber E, Lim U, Maskarinec G, Kolonel LN. Common immune-related risk factors and incident non-Hodgkin lymphoma: the multiethnic cohort. Int J Cancer. 2009 Sep 15;125(6):1440-5. doi: 10.1002/ijc.24456.

  PMID: 19444913 BACKGROUND

• Linabery AM, Prizment AE, Anderson KE, Cerhan JR, Poynter JN, Ross JA. Allergic diseases and risk of hematopoietic malignancies in a cohort of postmenopausal women: a report from the Iowa Women's Health Study. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1903-12. doi: 10.1158/1055-9965.EPI-14-0423. Epub 2014 Jun 24.

  PMID: 24962839 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Leukemia; Breast Neoplasms; Melanoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Laura E Beane Freeman, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 9, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 23, 2027
• Study Completion (Estimated): December 23, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-01-23

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)