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, 2020 - 2022
GUSEVA CANU, Irina, FITO, Carlos, BERGAMASCHI, Enrico, FRIESL, Judith, PROGIOU, Athena
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March 08, 2022
Last modified
May 03, 2022
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Identification
Survey ID Number
10.16909-DATASET-31
Title
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.
Country
| Name | Country code |
|---|---|
| Switzerland | CHE |
| Italy | ITA |
| Spain | ESP |
Abstract
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.
Kind of Data
1. Epidemiological questionnaire
2. Questionnaire for companies
2. Questionnaire for companies
Unit of Analysis
Companies and employees
Version
Version Description
Version 1.0
Version Date
2022-03-03
Scope
Keywords
| Keyword |
|---|
| NanoExplore |
| nanomaterials |
| nanoparticles |
| biomonitoring |
| biomarkers |
Coverage
Geographic Coverage
Switzerland, Italy, Spain
Producers and sponsors
Primary investigators
| Name | Affiliation |
|---|---|
| GUSEVA CANU, Irina | Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland |
| FITO, Carlos | Instituto Tecnológico del Embalaje, Transporte y Logística (ITENE), Valencia, Spain |
| BERGAMASCHI, Enrico | Laboratory of Toxicology and Industrial Epidemiology, Department of Public Health and Pediatrics, University of Torino, 10126 Torino, Italy |
| FRIESL, Judith | Yordas GmbH, 91301 Forchheim, Germany |
| PROGIOU, Athena | ALCON Consultant Engineers Ltd., 11257 Athens, Greece |
Producers
| Name | Affiliation | Role |
|---|---|---|
| Guseva Canu, Irina | Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | Project leader (lead center/site) |
| Plys, Ekaterina | Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Crézé, Camille | Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Fito López, Carlos | Instituto Tecnológico del Embalaje, Transporte y Logística (ITENE), Valencia, Spain | Local Project Leader at local center/site |
| Hopf, Nancy B. | Department of occupational and environmental health, Center for primary care and public health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Progiou, Athena | ALCON Consultant Engineers Ltd., 11257 Athens, Greece | Sponsor (for the NanoExplore European Consortium) |
| Riganti, Chiara | Department of oncology, University of Torino, Via Verdi 8, 10124 Torino, Italy | |
| Sauvain, Jean-Jacques | Department of occupational and environmental health, Center for primary care and public health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Squillacioti, Giulia | Department of public health and pediatrics, University of Torino, Via Verdi 8, 10124 Torino, Italy | |
| Suarez, Guillaume | Department of occupational and environmental health, Center for primary care and public health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Wild, Pascal | Department of occupational and environmental health, Center for primary care and public health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | |
| Bergamaschi, Enrico | Laboratory of Toxicology and Industrial Epidemiology, Department of Public Health and Pediatrics, University of Torino, 10126 Torino, Italy | Local Project Leader at local center/site |
Funding Agency/Sponsor
| Name |
|---|
| European Commission LIFE program (Grant LIFE17 ENV/GR/000285) |
Sampling
Sampling Procedure
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.
Data Collection
Dates of Data Collection
| Start | End |
|---|---|
| 2020-01-01 | 2022-06-01 |
Questionnaires
Questionnaires
Online questionnaires created and distributed via REDCap electronic data capture tool.
Access policy
Access authority
| Name | Affiliation | |
|---|---|---|
| Racine, Céline (Repository manager) | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | dfri.data@unisante.ch |
| Plys, Ekaterina (Research Fellow) | Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, 1066 Epalinges, Lausanne, Switzerland | ekaterina.plys@unisante.ch |
Confidentiality
Access conditions
Licensed datasets, accessible under conditions
To request access to licensed datasets, please register to the website to continue (https://data.unisante.ch/index.php/auth/register). Once your registration will be approved you must login and go to the "GET MICRODATA" tab and fill in the application form for access to the licensed dataset.
This form includes our Data access agreement and must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization.
This request will be reviewed by the Primary Investigator, who may decide to approve the request, to deny access to the data, or to request additional information from the Lead Researcher. A signed copy of this request form may also be requested.
If special conditions apply to the transfer of the requested data (e.g. transfer under a contract between Unisanté and a third party), the references of the contract concerned or the document in which the conditions are specified must be referenced in the request form. The person who makes the request will still need to check the box confirming the acceptance of the terms of use, it being understood that the conditions written in the above mentioned contract will apply.
To request access to licensed datasets, please register to the website to continue (https://data.unisante.ch/index.php/auth/register). Once your registration will be approved you must login and go to the "GET MICRODATA" tab and fill in the application form for access to the licensed dataset.
This form includes our Data access agreement and must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization.
This request will be reviewed by the Primary Investigator, who may decide to approve the request, to deny access to the data, or to request additional information from the Lead Researcher. A signed copy of this request form may also be requested.
If special conditions apply to the transfer of the requested data (e.g. transfer under a contract between Unisanté and a third party), the references of the contract concerned or the document in which the conditions are specified must be referenced in the request form. The person who makes the request will still need to check the box confirming the acceptance of the terms of use, it being understood that the conditions written in the above mentioned contract will apply.
Citation requirements
GUSEVA CANU, Irina, PLYS, Ekaterina, CRÉZÉ, Camille, FITO, Carlos, HOPF, Nancy B., PROGIOU, Athena, RIGANTI, Chiara, SAUVAIN, Jean-Jacques, SQUILLACIOTI, Giulia, SUAREZ, Guillaume, WILD, Pascal, BERGAMASCHI, Enrico. A harmonized protocol for an international multicentric prospective study of nanotechnology workers: The NanoExplore project. Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland. Version 1.0 of the questionnaires (April 2020), provided by the Unisanté Research Data Repository. DOI:10.16909/DATASET/31
Disclaimer and copyrights
Disclaimer
The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
Copyright
(c) 2022, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland ; Instituto Tecnológico del Embalaje, Transporte y Logística (ITENE), Valencia, Spain ; University of Torino, 10126 Torino, Italy ; Yordas GmbH, 91301 Forchheim, Germany ; ALCON Consultant Engineers Ltd., 11257 Athens, Greece
Metadata production
DDI Document ID
10.16909-DATASET-31
Producers
| Name | Abbreviation | Role |
|---|---|---|
| Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | Unisanté | Data publisher |
DDI Document version
Version 1.0 (November 2021)