NCT06800586 Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
| NCT ID | NCT06800586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-09-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stefano Nava, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06800586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06800586 currently recruiting?
Yes, NCT06800586 is actively recruiting participants. Contact the research team at stefano.nava@aosp.bo.it for enrollment information.
Where is the NCT06800586 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy, Foggia, Italy.
Who is sponsoring the NCT06800586 clinical trial?
NCT06800586 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Stefano Nava, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 300 participants.
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