Clinical trial NCT06800586: Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
Official title: Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Lung Cancer (NSCLC)
Leukemia
Keywords: COPD
Lung cancer
leukemia
Air pollution
Never smoker
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:

* Age ≥ 18 years
* Patients with a diagnosis of COPD of any severity (FEV1/FVC \< 0.7 after bronchodilation test)
* Non-smokers according to ISS definition: patients who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Signature of informed consent

Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:

* Age ≥ 18 years
* Non-smokers according to ISS definition: subjects who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Absence of comorbidities related to the study (COPD, solid tumors, leukemia) in medical history
* Workers of the IRCCS AOU of Bologna, S. Orsola Polyclinic
* Signature of informed consent

Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:

* Age ≥ 18 years
* Patients with a diagnosis of lung neoplasm of any histotype and stage
* Non-smokers according to ISS definition: patients who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Signature of informed consent

Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:

* Age ≥ 18 years
* Non-smokers according to ISS definition: subjects who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Absence of comorbidities related to the study (COPD, solid tumors, leukemia) in medical history
* Workers of the IRCCS AOU of Bologna, S. Orsola Polyclinic
* Signature of informed consent

Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):

* Age ≥ 18 years
* Non-smokers according to ISS definition: patients who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Patients with a diagnosis of leukemia of any type
* Signature of informed consent

Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):

* Age ≥ 18 years
* Non-smokers according to ISS definition: subjects who declare having smoked less than 100 cigarettes (5 packs of 20) in their lifetime and are not currently smokers
* Absence of comorbidities related to the study (COPD, solid tumors, leukemia) in medical history
* Workers of the Hospital-University Company, Policlinico Riuniti di Foggia
* Signature of informed consent

Exclusion Criteria:

Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:

* Deficiency of alpha-1 antitrypsin (A1AT)

Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:

* Workers from the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna, S. Orsola Polyclinic

Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:

* Previous and/or current diagnosis of solid tumors, myelodysplastic syndromes, myeloproliferative neoplasms
* Previous and/or current treatment with antineoplastic agents

Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:

* Workers from the Department of Medical Oncology, IRCCS AOU of Bologna, S. Orsola Polyclinic

Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):

* Previous diagnosis of solid tumors, myelodysplastic syndromes, myeloproliferative neoplasms
* Previous treatment with antineoplastic agents (alkylating agents, hydroxyurea, topoisomerase II inhibitors, lenalidomide) -Presence of pre-existing genetic conditions (Fanconi anemia, ataxia- telangiectasia, Down syndrome, xeroderma pigmentosum, Li-Fraumeni syndrome)
* Infection with human immunodeficiency virus (HIV), human T-lymphotropic virus types 1 or 2, or Epstein-Barr virus

Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):

* Workers from the Hematology Department, Hospital-University Company, Policlinico Riuniti di Foggia

Primary outcomes:
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
measure: Identification of pollutants in biological samples
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
Secondary outcomes:
measure: 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.
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months.
measure: Identification of potential effect biomarkers involved in the response to pollutants.
timeFrame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Bologna
country: Italy
facility: Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
city: Foggia
country: Italy
facility: Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Stefano Nava, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.