Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects

NCT ID: NCT06800586

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-08-31

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.

Conditions

COPD; Lung Cancer (NSCLC); Leukemia

Keywords

COPD; Lung cancer; leukemia; Air pollution; Never smoker

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Partecipant

• 50 patients with a histological diagnosis of lung cancer of any histotype and grade according to the World Health Organization (WHO) classification.
• 50 patients with a diagnosis of COPD according to the ERS/ATS guidelines and GOLD recommendations. The current guidelines define COPD as a chronic lung disease characterized by debilitating symptoms (such as dyspnea, chronic cough with sputum) and caused by exposure to toxic substances such as cigarette smoke and environmental pollutants. The diagnosis is based on the presence of airflow obstruction that is not completely reversible, identified by an FEV1/FVC ratio of <0.7 after bronchodilation testing in subjects with a compatible history.
• 50 patients with a histological diagnosis of leukemia according to the WHO classification.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Nava, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia

Foggia, Foggia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Nava, MD

Role: CONTACT

Phone: +39 0512143253

Email: stefano.nava@aosp.bo.it

Francesco Saverio Violante, MD

Role: CONTACT

Email: francesco.violante@unibo.it

Facility Contacts

Andrea Ardizzoni, MD

Role: primary

Stefano Nava, MD

Role: primary

Francesco Bellanti, MD

Role: primary

References

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.

Reference Type: RESULT

PMID: 34997503 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36732083 (View on PubMed)

Other Identifiers

RECAP

Identifier Type: -

Identifier Source: org_study_id

PNRR-MCNT1-2023-12378402

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id