Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects (NCT06800586) | Clinical Trial Compass
RecruitingNot Applicable
Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
Italy300 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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."
2
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."
3
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."
4
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."
5
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."
6
Identification of pollutants in biological samples
Trial details
NCT IDNCT06800586
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
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."