Abstract

Nanotechnology applications are fast-growing in many industrial fields. Consequently, health effects of engineered nanomaterials (ENMs) should be investigated. Within the EU-Life project NanoExplore, we developed a harmonized protocol of an international multicenter prospective cohort study of workers in ENM-producing companies. This article describes the development of the protocol, sample size calculation, data collection and management procedures and discusses its relevance with respect to research needs. Within this protocol, workers’ ENM exposure will be assessed over four consecutive working days during the initial recruitment campaign and the subsequent follow-up campaigns. Biomonitoring using noninvasive sampling of exhaled breath condensate (EBC), exhaled air, and urine will be collected before and after 4-day exposure monitoring. Both exposure and effect biomarkers, will be quantified along with pulmonary function tests and diagnosed diseases reported using a standardized epidemiological questionnaire available in four languages. Until now, this protocol was implemented at seven companies in Switzerland, Spain and Italy. The protocol is well standardized, though sufficiently flexible to include company-specific conditions and occupational hygiene measures. The recruitment, to date, of 140 participants and collection of all data and samples, enabled us launching the first international cohort of nanotechnology workers. All companies dealing with ENMs could join the NanoExplore Consortium, apply this harmonized protocol and enter in the cohort, concieved as an open cohort. Its protocol meets all requirements of a hypotheses-driven prospective study, which will assess and reassess effects of ENM exposure on workers’ health by updating the follow-up of the cohort. New hypothesis could be also considered.

摘要

纳米技术在许多工业领域的应用正在快速增长。因此，应该研究工程纳米材料 (ENM) 对健康的影响。在 EU-Life 项目 NanoExplore 中，我们制定了一项针对 ENM 生产公司工人的国际多中心前瞻性队列研究的协调方案。本文介绍了协议的开发、样本量计算、数据收集和管理程序，并讨论了其与研究需求的相关性。在此协议中，将在初始招聘活动和随后的后续活动期间连续四个工作日评估工人的 ENM 暴露情况。在 4 天暴露监测前后，将收集呼出气冷凝物 (EBC)、呼出空气和尿液的无创采样进行生物监测。暴露和影响生物标志物将与肺功能测试一起量化，并使用以四种语言提供的标准化流行病学问卷报告诊断的疾病。到目前为止，该协议已在瑞士、西班牙和意大利的七家公司实施。该协议标准化程度很高，但足够灵活，可以包括公司特定的条件和职业卫生措施。迄今为止，招募了 140 名参与者并收集了所有数据和样本，使我们能够启动第一批国际纳米技术工作者。所有与 ENM 打交道的公司都可以加入 NanoExplore 联盟，应用这个统一的协议并进入队列，被认为是一个开放的队列。它的协议满足假设驱动的前瞻性研究的所有要求，它将通过更新队列的后续行动来评估和重新评估 ENM 暴露对工人健康的影响。也可以考虑新的假设。