Air pollution biomarkers in people with COPD, lung cancer, and leukemia

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

This project will test whether air pollution-related biomarkers appear in never-smokers with COPD, non-small cell lung cancer, or leukemia compared with healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Locations: 3 sites (Bologna, Bologna and 2 other locations)
• Trial ID: NCT06800586 on ClinicalTrials.gov

What this trial studies

This observational effort will measure individual-level exposure to atmospheric pollutants and related biological markers in never-smokers diagnosed with COPD, NSCLC, or leukemia alongside healthy volunteer controls. Participants will be recruited through respiratory, oncology, and hematology departments in Bologna and Foggia and will attend scheduled clinic visits for exposure and biosample collection. The protocol focuses on never-smokers to reduce confounding by tobacco and seeks to improve on prior studies that relied on area-level exposure estimates by obtaining personal exposure data. Results aim to clarify mechanisms by which pollution contributes to these diseases and to identify candidate biomarkers of exposure and early effect.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) who are never-smokers and have COPD, non-small cell lung cancer, or leukemia, or healthy never-smoking hospital workers willing to serve as controls.

Not a fit: Current smokers, people under 18, patients with unrelated active comorbidities, or those unable to attend the Bologna or Foggia sites are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the work could identify measurable biomarkers that help detect, delay, or prevent pollution-related respiratory and blood cancers.

How similar studies have performed: Previous research has linked air pollution to these diseases but most used area-level exposure estimates, so applying individual exposure measurements and biomarker analyses is relatively novel and not yet widely validated.

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

Where this trial is running

Bologna, Bologna and 2 other locations

• Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
• Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
• Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia — Foggia, Foggia, Italy (RECRUITING)

Study contacts

• Principal investigator: Stefano Nava, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Stefano Nava, MD

Conditions: COPD, Lung Cancer, Leukemia, Lung cancer, leukemia, Air pollution, Never smoker