Air pollution biomarkers in people with COPD, lung cancer, and leukemia
Official title: Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06800586 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 3 sites (Bologna, Bologna and 2 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | July 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT06800586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: stefano.nava@aosp.bo.it
- Phone: +39 0512143253
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Understanding what patients want from NSCLC treatment monitoring
Researchers are testing how patients with non-small cell lung cancer feel about and prefer monitoring their symptoms during treatment, with input from patients, caregivers, and clinicians.
-
AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer
This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.
-
PD-L1-targeted PET probe to map PD-L1 in solid tumors
A PET tracer called 18F-F-PDL1-3 is being tested to see if it can detect PD-L1 expression in primary and metastatic tumors to help guide personalized treatment.
-
Cardiorespiratory fitness after lobectomy versus sublobar resection in NSCLC
This study tests how different lung surgeries (lobectomy vs. sublobar resection) affect fitness levels after surgery in people with non-small cell lung cancer.
-
CAIX-targeted PET/CT imaging in solid tumors
Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.