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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Identification of pollutants in biological samples — 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 — 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 — 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 — 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 — 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 — 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
Trial sites (3)
Facility
City
Region
Status
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Bologna
Recruiting
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna
Bologna
Recruiting
Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia
Foggia
Foggia
Recruiting
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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