NCT01399411

Brief Summary

Background: \- The Agricultural Health Study (AHS) is looking at the long-term health effects of farming exposures including pesticides, crops, and animals. The chronic health effects of exposure to pesticides are easier to study in farmers and their spouses. They know what chemicals they use and tend to live in the same place for most of their adult lives. AHS participants are expected to report any changes in their health. This includes any new medical conditions. Researchers want to follow up on these reports to confirm their accuracy. Objectives: \- To follow up AHS participants who have self-reported that they have a new disease and confirm their diagnosis. Eligibility: \- Current AHS participants. Design:

  • Researchers will confirm self-reported changes in medical conditions by contacting the AHS participant to ask for more information.
  • The AHS participant will give permission for researchers to contact their doctor to look at their medical records. They will also be asked to provide a cheek swab or saliva sample.
  • Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other diseases will be followed up in the future. Other diseases will be followed up in the future.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
89,656

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

July 5, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
Last Updated

May 29, 2026

Status Verified

September 16, 2025

First QC Date

July 20, 2011

Last Update Submit

May 28, 2026

Conditions

Keywords

Self-ReportedFarmingAgricultureDisease ValidationAutoimmune DisordersNatural History

Outcome Measures

Primary Outcomes (1)

  • The purpose of the current protocol is three-fold: 1) update information on medical history and other important covariates through ongoing follow-up interviews of the cohort; 2) validate self-reported diseases among cohort participants over the ...

    Changes in health over time.

    Various phases of follow-up; diseases are validated as they are ascertained

Study Arms (1)

AHS Cohort

licensed pesticide applicators and their spouses from Iowa and North Carolina already enrolled in the Agricultural Health Study (AHS)

Eligibility Criteria

Age24 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current Agricultural Health Study (AHS) participants (licensed pesticide applicators and their spouses from Iowa and North Carolina)

You may not qualify if:

  • All members of the AHS cohort who were eligible for the Phase 3 interview were eligible for the Phase 4 health follow-up. We will apply the same eligibility criteria for future cohort-wide follow-ups. Individuals who only completed the enrollment questionnaire were excluded from Phase 3 eligibility. Depending upon the disease outcome of interest, we may conduct the disease confirmation and validation efforts under this protocol among all participants in the AHS who provided self-reported diagnoses at any interview (e.g. Baseline, or Phases 2-4). For individuals who are unable to participate, we will allow a proxy to provide the information.
  • For the validation efforts, individuals who do not confirm their diagnosis of interest (via self or proxy report) will not be asked to provide physician contact for medical records. For specimen collection, we will ask the proxy respondent about whether the individual would be able to provide a sample. In order to obtain MRR we will allow the participant or their medical proxy to sign the form. For cases who are cognitively impaired or deceased, a medical proxy will be identified.
  • Determination of cognitive impairment will be made by report of proxy or by interviewer during conversation with participant. Because the AHS enrolled husband - wife pairs, we should be able to identify an appropriate proxy for most participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Illinois, 52242, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Batelle, Inc.

Columbus, Ohio, 43201, United States

Location

MeSH Terms

Conditions

AsthmaParkinson DiseaseAutoimmune Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Dale P Sandler, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 21, 2011

Study Start

July 5, 2011

Last Updated

May 29, 2026

Record last verified: 2025-09-16

Locations