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| ID | Type | Description | Link |
|---|---|---|---|
| PNRR-MCNT1-2023-12378402 | Other Grant/Funding Number | Ministero della Salute |
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This study aims to examine the exposure to atmospheric pollutants in a group of non-smoking patients suffering from lung cancer, chronic obstructive pulmonary disease (COPD), and leukemia. The exposure to atmospheric pollutants will be assessed simultaneously in a group of healthy volunteers. The ultimate goal of the study is to enhance the understanding of the mechanisms by which atmospheric pollutants act, in order to develop new tools that can help halt or at least delay the development of diseases associated with pollution.
Atmospheric pollution represents a global issue today. A significant portion of the population in Italy lives in areas where air quality standards are very low, both due to global warming and human-caused pollution. This not only poses a serious risk to human health but also has a tremendous economic and social impact on the National Health System. Atmospheric pollution is associated with a variety of diseases affecting nearly all organs and systems.
In almost all currently available studies on atmospheric pollution and its effects on humans, the population's exposure to pollutants is not measured at the individual level; instead, it is estimated using various environmental sampling techniques based on geographical areas and then applied to individuals based on their residence. There is also a lack of information regarding the effects of confounding risk factors, especially concerning cigarette smoking.
This study aims to acquire more information on the individual exposure to pollutants in a group of non-smoking patients suffering from lung cancer, COPD, and leukemia. The decision to evaluate only never-smokers ensures that there are no confounding factors in the association study between health and environmental pollution.
During a scheduled visit at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna, the Department of Medical Oncology, IRCCS AOU of Bologna, and the Department of Hematology, Hospital-University Company, Policlinico Riuniti di Foggia, and after obtaining informed consent, the following biological samples will be collected in a non-invasive manner and in small aliquots: exhalate, respiratory condensate, sputum, blood, and urine. The collected samples will then be analyzed by the laboratories of the Occupational Medicine Department (IRCCS - AOU of Bologna) and the Messina Institute of Technology (MeIT) of the Department of Chemical, Biological, Pharmaceutical, and Environmental Sciences (CHIBIOFARAM) of the University of Messina using advanced techniques such as electron microscopy, mass spectrometry chromatography, and for the determination of pollutants such as particulate matter and volatile compounds. Furthermore, the project also aims to identify effect biomarkers involved in the response to such agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | 150 healthy controls will be recruited as volunteers in the pool of employees of the participating healthcare companies, excluding the participating operational units | ||
| Partecipant |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of pollutants in biological samples | -Scanning Electron Microscopy (SEM): presence of inorganic and organic particulate matter | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| Identification of pollutants in biological samples | -Transmission Electron Microscopy (TEM): presence of inorganic and organic particulate matter | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| Identification of pollutants in biological samples | -Atomic Force Microscopy (AFM): presence of inorganic and organic particulate matter | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| Identification of pollutants in biological samples | -Infrared (IR) and Raman Spectroscopy: presence of inorganic and organic particulate matter | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| Identification of pollutants in biological samples | -Inductively Coupled Plasma Mass Spectrometry (ICP-MS): presence of metals | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| Identification of pollutants in biological samples |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the association between the identified pollutants and the development of COPD, lung cancer, and leukemia in a population of patients who have never smoked. | The objective will be measured by comparing the concentration (units/volume) of the identified pollutants within the biological samples of patients affected by lung cancer, COPD, and leukemia with those identified in the biological samples of healthy subjects, collected through:
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Inclusion Criteria:
Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Exclusion Criteria:
Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
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The study population consists of patients affected by COPD, lung cancer, and leukemia, attending the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna, the Department of Medical Oncology, IRCCS AOU of Bologna, and the Hematology Department, Hospital-University Company, Policlinico Riuniti di Foggia.
Healthy controls will also be recruited as volunteers from the pool of employees of the participating healthcare facilities, excluding the participating operating units.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Nava, MD | Contact | +39 0512143253 | stefano.nava@aosp.bo.it | |
| Francesco Saverio Violante, MD | Contact | francesco.violante@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Nava, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34997503 | Result | Sun Q, Wang B, Xu S, Cong X, Pu Y, Zhang J. Research development and trends of benzene-induced leukemia from 1990 to 2019-A bibliometric analysis. Environ Sci Pollut Res Int. 2022 Feb;29(7):9626-9639. doi: 10.1007/s11356-021-17432-3. Epub 2022 Jan 8. | |
| 36732083 | Result | Wang X, Chen L, Cai M, Tian F, Zou H, Qian ZM, Zhang Z, Li H, Wang C, Howard SW, Peng Y, Zhang L, Bingheim E, Lin H, Zou Y. Air pollution associated with incidence and progression trajectory of chronic lung diseases: a population-based cohort study. Thorax. 2023 Jul;78(7):698-705. doi: 10.1136/thorax-2022-219489. Epub 2023 Feb 2. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Blood, Urine, Sputum, Exhaled air, Breath condensate
-Gas Chromatography-Mass Spectrometry (GC-MS): presence of volatile compounds (e.g., VOCs) and semi-volatile compounds
| The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." |
| The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months. |
| Identification of potential effect biomarkers involved in the response to pollutants. | The objective will be measured by evaluating the alteration of endogenous molecule content (biomarkers) in the presence of the identified pollutants through the conduction of dose-response curves. High-Performance Liquid Chromatography/Mass Spectrometry (HPLC-MS) Gas Chromatography-Mass Spectrometry (GC-MS) | The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months |
| Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
|
| Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia | Recruiting | Foggia | Foggia | 71122 | Italy |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |