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

Overview

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.

Primary outcome measures

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

Secondary outcome measures (1)

• 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]

Eligibility criteria

• INCLUSION CRITERIA:

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 childhood or otherwise had agricultural exposures as a child (e.g., lived on a farm regularly; visited a farm; helped with farm work; or was exposed to farm chemicals, dust, or other farm-related materials).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 1 center

• National Cancer Institute (NCI) — Bethesda

Publications

• 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
• 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 ch PMID 31054169
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07328516 · 10002253 · 002253-C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗