Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Environmental Health Sciences (NIEHS) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00341198 |
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:
Condition |
---|
Autoimmune Disease |
Study Type: | Observational |
Official Title: | Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study |
Estimated Enrollment: | 700 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | December 2006 |
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).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, North Carolina | |
Battelle Centers for Public Health Research and Evaluation | |
Durham, North Carolina, United States, 27713 | |
NIEHS, Research Triangle Park | |
Research Triangle Park, North Carolina, United States, 27709 |
Study ID Numbers: | 999902166, 02-E-N166 |
Study First Received: | June 19, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00341198 |
Health Authority: | United States: Federal Government |
Rheumatoid Arthritis Lupus Scleroderma Sjogren's Syndrome |
Farming Autoimmune Disease Exposure |
Autoimmune Diseases Arthritis Arthritis, Rheumatoid Sjogren's Syndrome |
Immune System Diseases |