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NCT00341198 · ClinicalTrials.gov registry record
Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 700
- Enrollment target
NCT00341198: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00341198 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 700 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341198 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 700 participants
- Enrollment target
Study 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2002-04-02 |
| Est. Completion | 2006-12-12 |
What the finished NCT00341198 record still lists
NCT00341198 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00341198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341198 about?
NCT00341198 is a clinical study titled "Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study". 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 be...
What is the current status of trial NCT00341198?
This trial is currently completed. The enrollment target is 700 participants. The study started on 2002-04-02. Estimated completion is 2006-12-12.
Who is sponsoring clinical trial NCT00341198?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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