Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
Recruiting · NCT06800586 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
3 locations listed.
- Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Bologna, Italy
- Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna - Bologna, Bologna, Italy
- Ematology Unit, Azienda Ospedaliero-Universitaria, Policlinico Riuniti di Foggia - Foggia, Foggia, Italy