deltatrials
Completed OBSERVATIONAL NCT00341198

Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Updated 6 times since 2017 Last updated: Jun 30, 2017 Started: Apr 2, 2002 Completion: Dec 12, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00341198, this observational or N/A phase trial focuses on Autoimmune Disease and remains completed. Sponsored by National Institute of Environmental Health Sciences (NIEHS), it has been updated 6 times since 2002, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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).

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).

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Jun 2018 — Jan 2021 [monthly]

    Completed

  5. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

Show 1 earlier version
  1. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Apr 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Environmental Health Sciences (NIEHS)
Data source: National Institutes of Health Clinical Center (CC)

For direct contact, visit the study record on ClinicalTrials.gov .