NCT02884232已完成不适用
Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation
Central Hospital, Nancy, France6 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- Participation to medical supervision program of professionally active asymptomatic workers
研究概览
简要总结
The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.
Secondary purposes are:
- Feasibility evaluation of identification of former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics in case of co-expositions (formaldehyde, chrome, nickel, leather)
- Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test
- Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases
- Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program
- Evaluation of information flow among different players
- Assessment of costs induced by this targeted screening: direct medical costs (screened pathologies, induced additional examinations...) and indirect costs for company (duration of worker absence for transfer, medical and additional examinations).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 44 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Employee or craftsman
- •Actual or former professional exposition to wood dust
- •Onset of exposition to wood dust back to more than 30 years (latency >30 years)
- •Cumulated exposition to wood dust longer than 12 months
- •Exposition to wood dust during machining tasks (sawing, milling, planing, drilling, bridging) or all documented activities exposing to wood dust concentration > 1 mg/m3 for 8 hours
- •Worker followed by occupational doctor of participant occupational health departments
- •Worker accepting medico-professional supervision recommended by guidelines
- •Affiliation to social security
排除标准
- •Difficulty with comprehension of wood auto-questionnaire
结局指标
主要结局
Participation to medical supervision program of professionally active asymptomatic workers
时间窗: 27 months
次要结局
- Former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics(Day 0)
- Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test(24 months)
- Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy(27 months)
- Participation to medical supervision program of workers retiring in 2 years after inclusion(Day 0)
- Evaluation of information flow among different players(27 months)
- Medical costs Induced by screening(27 months)
研究者
研究点 (6)
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