Local Health Authority of Taranto
Taranto, 74121, Italy
NCT Number: NCT06591988
This study is part of the MISTRAL project, funded by the European Commission under the Horizon Europe Program, within the Work Programme 2021-2022 of Pillar II - Health Cluster on Environment and Health, which has the main objective of creating a cloud-based informatics platform for Health Impact Assessment analysis that, thanks to artificial intelligence, is able to simulate different clinical scenarios, economic and social, before and after the introduction of environmental risk mitigation policies, starting from data and evidence derived from case studies (several European cities) with different levels of exposure to environmental, health, geographical and socio-economic factors. The Project involves 11 partners distributed among Italy (Istituto Superiore di Sanità, Azienda Sanitaria Locale di Taranto, University of Bari, Politecnico di Bari, APS PLANET), Belgium (University of Hasselt), Poland (AGH-University of Technology and Science), Germany (Nuromedia), Spain (Ubitel), Greece (WINGS-ICT Solutions) and England (University of Oxford, University of Suffolk).
Specifically, the ZEPHYR study is a cross-sectional (cross-sectional), population-based, multicenter survey. The centers involved are the ASL of Taranto with the Taranto City Single District (Coordinating Recruitment Center), the University of Hasselt, Belgium (Recruitment Center Hasselt Hospital Campus), and the University of Krakow, Poland (Rybnik University Hospital as recruitment center).
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Observational
Taranto, 74121, Italy
The purpose of the cross-sectional interventional survey is to directly measure the population most susceptible to environmental determinants, the frequency of multidimensional variables, and the conditions that may change their health status. Specifically, the survey has two main objectives, corresponding to two outcomes to be investigated separately in the same populations.
Black carbon assay will be considered as a proxy for exposure to pollutants specifically related to steel production. This has been identified as one of the most promising biomarkers in terms of evidence of both deterministic and stochastic biological damage, in particular in the pediatric population,3 and it has even been demonstrated in fetal exposure4. In addition, the huge amount of urine samples collected will lead to the creation of a urine biobank for further (eventual) molecular analysis. Quality of life will be measured directly in different subpopulations, to be used to construct individual surrogate QALY scores.
On the sidelines of these macro objectives, however, additional biomarkers will be analyzed in the tissues of consenting subjects.
Specifically, the following will be analyzed :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
introduction of environmental risk mitigation policies, from data and evidence from case studies (several European cities) with different levels of exposure to environmental, health, geographic, and socioeconomic factors.
Other names: environmental risk mitigation policies
Time frame: baseline and 2 years
quality-adjusted life-year. QALY scores range from 1 (perfect health) to 0 (dead)
Time frame: baseline and 2 years
Disability Adjusted Life Years. Disability-adjusted life years (DALYs) are a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability, or early death.
Azienda Sanitaria Locale di Taranto
Other Gov
A Multicenter Study to Identify Determinants Associated With Black Carbon Concentration in Biological Samples and Predictors of Quality of Life in Different Subpopulations Distinguished by Age Group and Residence
Acronym: ZEPHYR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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