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

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ID
NCT06800586
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Jan 30, 2025
Start date
Sep 15, 2025
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

Identification of pollutants in biological samples [ Time Frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months." ]

Central Contacts

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