Clinical trial · Observational
Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
NCT06800586CI-TRIAL-00099322RECAPrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COPD | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Healthy Controls
- description
- 150 healthy controls will be recruited as volunteers in the pool of employees of the participating healthcare companies, excluding the participating operational units
- label
- Partecipant
- description
- * 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.
Primary outcomes (6)
- measure
- Identification of pollutants in biological samples
- timeFrame
- The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSun 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
- RESULTWang 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