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

NCT06800586 | Recruiting

• 2 other identifiers: RECAPPNRR-MCNT1-2023-12378402
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

COPD; Lung Cancer (NSCLC); Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

  -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."

Secondary Outcomes (2)

• 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 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 collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months

Study Arms (2)

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

* 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (3)

Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

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

Bologna, Bologna, 40138, Italy

RECRUITING

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

Foggia, Foggia, 71122, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 34997503 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.

  PMID: 36732083 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine, Sputum, Exhaled air, Breath condensate

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Leukemia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stefano Nava, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nava, MD

CONTACT

+39 0512143253; stefano.nava@aosp.bo.it

Francesco Saverio Violante, MD

CONTACT

francesco.violante@unibo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 30, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)