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Por invitaciónNCT07328516Registro de ClinicalTrials.gov

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

Prostate Cancer · Leukemia · Breast Cancer · Melanoma · Colorectal Cancer

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - 99 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
64277 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

...

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

  • 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 Agricultural Health Study - A Prospective Study of Cancer and Other Diseases among Men and Women in Agriculture (OH93NCN013)).
3. 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).
4. 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.

Población del estudio

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Incidence of Cancer

Plazo: Enrollment over 5 years, ongoing follow-up for life or until study end

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.

Medidas secundarias

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

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

To assess the effect of non-agricultural exposures on the risk of cancer and other diseases in children and adults. The study will also track survival and collect molecular biomarker data to better understand additional health outcomes beyond cancer.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

National Cancer Institute (NCI)Bethesda, Maryland, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
National Cancer Institute (NCI)
Inicio del estudio
15 nov 2026 Estimado
Finalización primaria
23 dic 2027 Estimado
Finalización del estudio
23 dic 2030 Estimado
Primera publicación
9 ene 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026