Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Italy
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
RECRUITING
Bologna
Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia
RECRUITING
Foggia
Contact Information
Primary
Stefano Nava, MD
stefano.nava@aosp.bo.it
+39 0512143253
Backup
Francesco Saverio Violante, MD
francesco.violante@unibo.it
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 300
Treatments
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.
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov