COPDRECAPNCT06800586
Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
An observational study of COPD and Lung Cancer (NSCLC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Lung Cancer (NSCLC), Leukemia
- How many people
- 300 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Sep 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Francesco Saverio Violante, MD contact
Italy3 sites, 3 recruiting
- Recruiting
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Andrea Ardizzoni, MD, andrea.ardizzoni@aosp.bo.it
Andrea Ardizzoni, MD
- Recruiting
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bologna, 40138
Stefano Nava, MD, stefano.nava@aosp.bo.it
Stefano Nava, MD
- Recruiting
Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia
Foggia, Foggia, 71122
Francesco Bellanti, MD, francesco.bellanti@unifg.it
Francesco Bellanti, MD
About this study
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.
Read the 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of pollutants in biological samples
-Scanning Electron Microscopy (SEM): presence of inorganic and organic particulate matter
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 objective will be measured by comparing the concentration (units/volume) of the identified pollutants within the biological samples of patients affected by lung cancer, COPD, and leukemia with those identified in the biological samples of healthy subjects, collected through:
- Scanning Electron Microscopy (SEM): presence of inorganic and organic -particulate matter
- Transmission Electron Microscopy (TEM): presence of inorganic and organic particulate matter
- Atomic Force Microscopy (AFM): presence of inorganic and organic particulate matter
- Infrared (IR) and Raman Spectroscopy: presence of inorganic and organic particulate matter
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS): presence of metals Gas Chromatography-Mass Spectrometry (GC-MS): presence of volatile compounds (e.g., VOCs) and semi-volatile compounds
Measured: 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 objective will be measured by evaluating the alteration of endogenous molecule content (biomarkers) in the presence of the identified pollutants through the conduction of dose-response curves.
High-Performance Liquid Chromatography/Mass Spectrometry (HPLC-MS) Gas Chromatography-Mass Spectrometry (GC-MS)
Measured: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start15 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nava, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800586
- Sponsor's protocol ID
- RECAP
- Other IDs
- PNRR-MCNT1-2023-12378402
- Acronym
- RECAP
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34997503Wang 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.
PubMed 36732083
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
- ClinicalTrials.gov ID
- NCT06800586
- Acronym / sponsor ID
- RECAP / RECAP
- Conditions
- COPD, Lung Cancer (NSCLC), Leukemia
- Keywords
- COPD, Lung cancer, leukemia, Air pollution, Never smoker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (33 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Scanning Electron Microscopy (SEM): presence of inorganic and organic particulate matter
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Transmission Electron Microscopy (TEM): presence of inorganic and organic particulate matter
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Atomic Force Microscopy (AFM): presence of inorganic and organic particulate matter
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Infrared (IR) and Raman Spectroscopy: presence of inorganic and organic particulate matter
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Inductively Coupled Plasma Mass Spectrometry (ICP-MS): presence of metals
Identification of pollutants in biological samples
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Gas Chromatography-Mass Spectrometry (GC-MS): presence of volatile compounds (e.g., VOCs) and semi-volatile compounds
2 secondary outcomes
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.
Time frame: 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.
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 34997503Sun 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.
- Results publication: PubMed 36732083Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Saverio Violante, MD contact
Stefano Nava, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Lung Cancer (NSCLC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Nava, MD (+39 0512143253, stefano.nava@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of pollutants in biological samples (time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.