NanoExplore – A pilot study to demonstrate the feasibility of a harmonized approach and validate a choice of biomarkers for exposure and health effects monitoring of nanomaterials in workplaces and urban areas. - Switzerland, Italy, Spain

Abstract
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Nanotechnologies is a fast-growing field that employs thousands of workers. However, effects of nanoparticles on human health in occupational setting are not completely understood. The aim of this longitudinal multicenter prospective cohort study is to develop an integrated approach for investigation of human health outcomes related to exposure to nanoparticles. Three groups of nanotechnology workers will be recruited in Switzerland, Spain and Italy. “Exposed” (n=80) and “Internal control” (n=40) groups will be recruited from companies manufacturing nanomaterials. “Exposed” group will include individuals who produce or handle nanomaterials, whereas “Internal control” group will include non-exposed individuals from the same companies, e.g., administrative employees. “Universal control” (n=40) group will include individuals from companies with confirmed absence of exposure to nanomaterials. Biomarkers of exposure and effect will be measured in the participants before and after a 4-day monitoring of external exposure (on Monday morning and on Thursday evening) at recruitment and at the 6/9 months follow-up (four times in total). The biomarkers will be analyzed from exhaled breath condensate, expired air and urine samples. Implementation of an integrated and harmonized biomonitoring protocol in occupational settings should demonstrate the feasibility of similar research project in the future, facilitate further epidemiological studies and health surveillance programs, and inform stakeholders of regulatory aspects targeting occupational exposure to engineered and incidental nanoparticles.

Geographic coverage
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Switzerland, Italy, Spain

Analysis unit
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Companies and employees

Kind of data
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1. Epidemiological questionnaire
2. Questionnaire for companies

Sampling procedure
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The recruitment will be conducted following a two-step procedure. First, eligible companies will be recruited using professional contacts previously established by members of the NanoExplore Consortium and via an announcement posted on the NanoExplore website. Next, an information visit will be organized to the companies that gave their agreement to participate in the study. During this visit, a member of the NanoExplore Consortium will explain study objectives, procedure and potential risks and benefits related to participation in the study. Workers willing to participate will be provided with detailed information about data collection procedures. Moreover, during the information visit, a company questionnaire will be administrated to managers or health & safety specialists in order to collect standardized information on company activities, processes at risk for ENMs exposure, equipment and infrastructure already available for protection of their employees. The questionnaires can be filled in online using the REDCap electronic data capture tool.

Research instrument
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Online questionnaires created and distributed via REDCap electronic data capture tool.

{'Abstract': '纳米技术领域正处于快速发展阶段，吸纳了成千上万的劳动者。然而，在职业环境中，纳米颗粒对人体健康的影响尚未完全明了。本纵向多中心前瞻性队列研究旨在构建一种综合方法，以探究纳米颗粒暴露与人类健康结果之间的关系。研究将在瑞士、西班牙和意大利招募三组纳米技术工人。‘暴露组’（n=80）和‘内部对照组’（n=40）将从制造纳米材料的公司中招募。‘暴露组’将包括生产或处理纳米材料的个人，而‘内部对照组’将包括来自同一公司的非暴露个体，例如行政员工。‘通用对照组’（n=40）将包括那些在已确认无纳米材料暴露的公司中的个体。在招募时以及在6/9个月的随访中（总计四次），将在招募前后对参与者的暴露和效应生物标志物进行测量。这些生物标志物将从呼出气冷凝物、呼出气体和尿液样本中进行分析。在职业环境中实施一种综合且协调的生物监测方案，应证明未来类似研究项目的可行性，促进进一步的流行病学研究与健康监测计划，并向利益相关者提供针对职业暴露于工程和意外纳米颗粒的监管方面的信息。', 'Geographic coverage': '瑞士、意大利、西班牙', 'Analysis unit': '公司及员工', 'Kind of data': ['流行病学问卷', '公司问卷'], 'Sampling procedure': '招募将遵循两步程序。首先，将利用NanoExplore联盟成员之前建立的专业联系以及NanoExplore网站上的公告来招募符合条件的公司。其次，将组织对公司进行信息访问，这些公司已同意参与研究。在此次访问中，NanoExplore联盟成员将解释研究目标、程序以及与参与研究相关的潜在风险和益处。愿意参与研究的工人将获得关于数据收集程序的具体信息。此外，在信息访问期间，将对管理者或健康与安全专家进行公司问卷的发放，以收集有关公司活动、对纳米材料暴露风险的过程、为保护员工而现有的设备和基础设施的标准化信息。问卷可以通过REDCap电子数据采集工具在线填写。', 'Research instrument': '通过REDCap电子数据采集工具创建和分发的在线问卷。'}