Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study

June 30, 2017 updated by: National Institute of Environmental Health Sciences (NIEHS)

Autoimmune diseases may involve nearly any organ and are characterized by abnormal activation or response of certain cells. Evidence suggests that farm work, exposure to silica from farming activities and exposure to pesticides may contribute to the development of autoimmune disease. Associations between autoimmune diseases and farming, however, have not been extensively investigated, and exposure data in the currently available studies are extremely limited.

One of the major challenges in conducting population-based research on autoimmune diseases is case ascertainment. Self-report of previous diagnosis has proven to be unreliable. This protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren syndrome) within the Agricultural Health Study group (AHS; a group of licensed pesticide applicators and spouses who completed a questionnaire). The confirmed cases will constitute a refined case group to allow analyses of pesticides and other farming-related exposures as possible risk factors for these diseases using data that have already been collected.

Subjects will be selected from participants in the AHS who reported one of the diseases being studied. A short telephone interview will be conducted with participants, who will be requested to provide written consent for review of information from medical records. To confirm the self-diagnosis, participants' physicians will be contacted. Specific information will be requested in the form of a checklist. Responses will be reviewed for evidence of diagnosis and classified as confirmed, probable, physician-diagnosed, or unconfirmed.

Secondary objectives of this study are to:

  • assess the correct interpretation of conflicting self-reports that are provided at two different times.
  • evaluate the usefulness of specific questions that could potentially be used in future studies to validate self-reported cases of rheumatoid arthritis in men.

Study Overview

Status

Completed

Conditions

Detailed Description

Farming-related exposures (including pesticides and silica) may contribute to the etiology of autoimmune diseases. However, associations between autoimmune diseases and farming have not been extensively investigated, and exposure data in the currently available studies is extremely limited. One of the major challenges in conducting population-based research on autoimmune diseases is case ascertainment. Self-report of previous diagnosis has been shown to be very unreliable. This protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren syndrome) within the Agricultural Health Study (AHS) cohort. The confirmed cases will constitute a refined case group to allow etiologic analyses of pesticides and other farming-related exposures as possible risk factors for these diseases using data that have already been collected. The codes can also be used in a nested case-control study that could be designed to collect additional exposure data (for example, on silica-related exposures).

Study Type

Observational

Enrollment

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Battelle Centers for Public Health Research and Evaluation
      • Research Triangle Park, North Carolina, United States, 27709
        • NIEHS, Research Triangle Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Agricultural workers and their spouses.

EXCLUSION CRITERIA:

Children will not be included.

There are no exclusions based on ethnicity or race.

Participants who are unable to complete a telephone interview because of chronic illness (including cognitive impairment) or language or hearing difficulties will not be eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 2, 2002

Study Completion

December 12, 2006

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (ESTIMATE)

June 21, 2006

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

December 12, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999902166
  • 02-E-N166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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