NCT02743481

Brief Summary

Background: The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes. Objective: To study data to find links between early life farm exposure and negative health outcomes. Eligibility: There will be no human subjects. Design: Researchers will get public data in the two study states. This will come from things like: Birth certificates Driver s licenses Voter registration Death certificates Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA). Researchers will link ELEA data to cancer data. This will identify prevalence of cancer. They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides. Researchers will analyze the cancer and pesticide results and look for links.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

April 14, 2016

Last Update Submit

April 16, 2020

Conditions

Keywords

PesticideAgricultureCancerChildhoodLeukemia

Outcome Measures

Primary Outcomes (2)

  • Cancer incidence

    Cancer incidence

    Birth through 2014

  • Mortality

    Death

    Birth through 2014

Eligibility Criteria

Age7 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Offspring of Agricultural Health Study (AHS) cohort members (farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa).

You may qualify if:

  • children born to Agricultural Health Study (AHS) participants from 1975-2009.
  • individuals identified through questionnaire or through the probabilistic and deterministic match to the birth registries as being the offspring of the AHS participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Testicular NeoplasmsLeukemiaLymphomaBrain NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laura Beane-Freeman

    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

April 14, 2016

First Posted

April 19, 2016

Study Start

April 14, 2016

Primary Completion

April 15, 2020

Study Completion

April 15, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations