Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341198
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
Status:
COMPLETED
Status Verified Date:
2006-12-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-E-N166 | None | None | None |