Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Environmental Pollutants and Life Quality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEPHYR
Brief Summary:
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
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
Detailed Description:
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
1 Recruitment of 380 children 418 adults and 418 elderly These sample sizes will be those planned for each unit Taranto in Italy Rybnik in Poland and Genk-Hasselt County in Belgium
2 The areas of Tamburi an area presumably highly exposed to environmental pollutants and Talsano-Lama-San Vito will be selected for sampling in the city of Taranto
3 Administration of informed consents through general practitioners and pediatricians of free choice in the areas involved in recruitment
4 Collection of urine and blood samples to measure determinants associated with the concentration of black carbon BC in urine samples and other pollutants PCBs Benzene in blood and urine The collected exposure data will be used to create a pragmatic score dose-response function of environmental pollution contamination
5 Measurement of clinical social and environmental determinants and predictors of quality of life QoL measured using a specific validated multinational questionnaire the EQ-5D-5L and to create a probabilistic score using feature selection algorithms in machine learning that can predict different classes of QoL using clinical social and environmental determinants
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 population3 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
1 Benzene metabolites S-phenyl-mercapturic acid SPMAct- muconic acids
2 metabolites of PAHs the 1-hydroxypyrene 1-OHPyr
3 cotinine to identify smokers those exposed to secondhand smoke and in nonsmokers
4 PCR analysis for detection of telomere length indicators of aging
1 Recruitment of 380 children 418 adults and 418 elderly These sample sizes will be those planned for each unit Taranto in Italy Rybnik in Poland and Genk-Hasselt County in Belgium
2 The areas of Tamburi an area presumably highly exposed to environmental pollutants and Talsano-Lama-San Vito will be selected for sampling in the city of Taranto
3 Administration of informed consents through general practitioners and pediatricians of free choice in the areas involved in recruitment
4 Collection of urine and blood samples to measure determinants associated with the concentration of black carbon BC in urine samples and other pollutants PCBs Benzene in blood and urine The collected exposure data will be used to create a pragmatic score dose-response function of environmental pollution contamination
5 Measurement of clinical social and environmental determinants and predictors of quality of life QoL measured using a specific validated multinational questionnaire the EQ-5D-5L and to create a probabilistic score using feature selection algorithms in machine learning that can predict different classes of QoL using clinical social and environmental determinants
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 population3 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
1 Benzene metabolites S-phenyl-mercapturic acid SPMAct- muconic acids
2 metabolites of PAHs the 1-hydroxypyrene 1-OHPyr
3 cotinine to identify smokers those exposed to secondhand smoke and in nonsmokers
4 PCR analysis for detection of telomere length indicators of aging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None