Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study

NCT00341198 | Completed

• 2 other identifiers: 99990216602-E-N166
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Autoimmune Disease

Keywords

Rheumatoid Arthritis; Lupus; Scleroderma; Sjogren's Syndrome; Farming; Autoimmune Disease; Exposure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Agricultural workers and their spouses.

You may not qualify if:

• Children will not be included.
• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Battelle Centers for Public Health Research and Evaluation

Durham, North Carolina, 27713, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

• Jubault V, Penfornis A, Schillo F, Hoen B, Izembart M, Timsit J, Kazatchkine MD, Gilquin J, Viard JP. Sequential occurrence of thyroid autoantibodies and Graves' disease after immune restoration in severely immunocompromised human immunodeficiency virus-1-infected patients. J Clin Endocrinol Metab. 2000 Nov;85(11):4254-7. doi: 10.1210/jcem.85.11.6988.

  PMID: 11095463 BACKGROUND

MeSH Terms

Conditions

Autoimmune Diseases; Arthritis, Rheumatoid; Scleroderma, Diffuse; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Skin Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: April 2, 2002
• Study Completion: December 12, 2006
• Last Updated: July 2, 2017

Record last verified: 2006-12-12

Locations

US (3)