EnvironmentZEPHYRNCT06591988
Environmental Pollutants and Life Quality
An observational study of Environment and Pollution Exposure, run by Azienda Sanitaria Locale di Taranto at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Environment, Pollution Exposure, Mortality
- What is being tested?
- Lifestyle factors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 608 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Oct 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sampling frame will consist of the demographic dataset from regional health registries for each national unit. The survey will include children, adults, and the elderly, and probability sampling will be applied in each subpopulation, using a nearest neighbor matching algorithm and considering sex and age classes (5-year intervals) as matching covariates.
Who may be able to join
- Within the population of Taranto (southern Italy), healthy volunteer subjects will be recruited, and sampled from the following geographic areas of the city: the Tamburi district (an area presumably highly exposed to environmental pollutants), and the Talsano-Lama-San Vito district.
Who cannot join
- unhealthy subjects
- Taranto people residing outside the above areas
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- 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).
- 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.
- Administration of informed consents through general practitioners and pediatricians of free choice in the areas involved in recruitment.
- 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.
- 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 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 :
- Benzene metabolites: S-phenyl-mercapturic acid (SPMA)c,t- muconic acids;
- metabolites of PAHs: the 1-hydroxypyrene (1-OHPyr)
- cotinine to identify smokers, those exposed to secondhand smoke, and in nonsmokers.
- PCR analysis for detection of telomere length (indicators of aging)
- Conditions
- Environment, Pollution Exposure, Mortality, Healthcare, Lifestyle Factors
- Being tested
- Lifestyle factors
- Keywords
- environmental pollutants, lifestyle, mortality, risk factors, public health, life expectancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle factorsBehavioural
Also called environmental risk mitigation policies
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
QALY
quality-adjusted life-year. QALY scores range from 1 (perfect health) to 0 (dead)
Measured: baseline and 2 years
DALY
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.
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnvironmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 608 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale di Taranto
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roberta Zupo, Azienda Sanitaria Locale di Taranto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591988
- Sponsor's protocol ID
- 01/2024
- Acronym
- ZEPHYR
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06591988
- Acronym / sponsor ID
- ZEPHYR / 01/2024
- Conditions
- Environment, Pollution Exposure, Mortality, Healthcare, Lifestyle Factors
- Keywords
- environmental pollutants, lifestyle, mortality, risk factors, public health, life expectancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale di TarantoOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- 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).
- 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.
- Administration of informed consents through general practitioners and pediatricians of free choice in the areas involved in recruitment.
- 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.
- 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 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 :
- Benzene metabolites: S-phenyl-mercapturic acid (SPMA)c,t- muconic acids;
- metabolites of PAHs: the 1-hydroxypyrene (1-OHPyr)
- cotinine to identify smokers, those exposed to secondhand smoke, and in nonsmokers.
- PCR analysis for detection of telomere length (indicators of aging)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sampling frame will consist of the demographic dataset from regional health registries for each national unit. The survey will include children, adults, and the elderly, and probability sampling will be applied in each subpopulation, using a nearest neighbor matching algorithm and considering sex and age classes (5-year intervals) as matching covariates.
Key inclusion criteria (1 listed)
- Within the population of Taranto (southern Italy), healthy volunteer subjects will be recruited, and sampled from the following geographic areas of the city: the Tamburi district (an area presumably highly exposed to environmental pollutants), and the Talsano-Lama-San Vito district.
Key exclusion criteria (2 listed)
- unhealthy subjects
- Taranto people residing outside the above areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle factorsAlso: environmental risk mitigation policiesintroduction 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. | Behavioural | – |
Primary outcome
QALY
Time frame: baseline and 2 years
quality-adjusted life-year. QALY scores range from 1 (perfect health) to 0 (dead)
DALY
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- MISTRAL projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environment and Pollution Exposure, run by Azienda Sanitaria Locale di Taranto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QALY (time frame: baseline and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.