Guseva Canu Irina, Plys Ekaterina, Velarde Crézé Camille, Fito Carlos, Hopf Nancy B, Progiou Athena, Riganti Chiara, Sauvain Jean-Jacques, Squillacioti Giulia, Suarez Guillaume, Wild Pascal, Bergamaschi Enrico
Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Institutotecnológico del embalaje, transporte y logística (ITENE), Paterna, Spain.
Nanotoxicology. 2023 Feb;17(1):1-19. doi: 10.1080/17435390.2023.2180220. Epub 2023 Mar 16.
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.
纳米技术在许多工业领域的应用正在迅速增长。因此，应研究工程纳米材料（ENM）对健康的影响。在欧盟生命项目“纳米探索”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统一方案。本文描述了该方案的制定、样本量计算、数据收集和管理程序，并讨论了其与研究需求相关的内容。在该方案中，将在初次招募活动及后续随访活动期间，连续四个工作日评估工人的ENM暴露情况。在为期4天的暴露监测前后，将收集呼出气冷凝物（EBC）、呼出气体和尿液的非侵入性样本进行生物监测。暴露生物标志物和效应生物标志物都将进行量化，同时还将进行肺功能测试，并使用四种语言提供的标准化流行病学问卷报告诊断出的疾病。到目前为止，该方案已在瑞士、西班牙和意大利的七家公司实施。该方案标准化程度很高，但也足够灵活，能够纳入公司特定条件和职业卫生措施。迄今为止，已招募了140名参与者并收集了所有数据和样本，这使我们能够启动首个纳米技术工人国际队列。所有涉及ENM的公司都可以加入“纳米探索”联盟，应用这一统一方案并加入该队列，该队列被设想为一个开放队列。其方案满足假设驱动的前瞻性研究的所有要求，该研究将通过更新队列随访来评估和重新评估ENM暴露对工人健康的影响。也可以考虑新的假设。
