Immune Checkpoints in COPD
- Conditions
- Lung CancerCopdAsthmaSevere ARDS
- Interventions
- Other: check immune check points
- Registration Number
- NCT04654104
- Lead Sponsor
- University of Catanzaro
- Brief Summary
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
- Detailed Description
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
Patients will be recruited from from the outpatient clinics of the Pulmonary and Critical Care Medicine department of "Mauro Scarlato" Hospital in Scafati, Italy in collaboration with the Operational Unit of Clinical Pharmacology and Pharmacovigilance of Catanzaro University.
171 patients will be divided according to the results of the anatomopathological examinations into four groups:
* Healthy never smokers
* Smokers with normal lung
* Cancer
* COPD (COPD group was divided in two subgroups: GOLD 1-2 group and GOLD 3-4 group).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
-
• over 18 years of age with suspected diagnosis of pulmonary neoplasia
- signed the informed consent
-
• infected diseases
- interstitiopathy
- asthma,
- autoimmune diseases,
- neoplasia other than inclusion criteria
- subjects on glucocorticoid therapy
- alcohol consumption (>3 alcoholic beverages daily)
- substance abuse
- inability to give written informed consent
- those who will not sign the consent to the processing of personal data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COPD check immune check points evaluation of immune check points expression Lung cancer check immune check points evaluation of immune check points expression Smokers with normal lung function check immune check points evaluation of immune check points expression Healthy never smokers check immune check points Clinical evaluation of immune check points expression. A prospective study
- Primary Outcome Measures
Name Time Method CTLA-4 in bronchoalveolar lavage fluid 1 month to evaluate the expression of CTLA-4
PD-L1 in bronchoalveolar lavage fluid 1 month to evaluate the expression of PD-L1
PD-1 in bronchoalveolar lavage fluid 1 month to evaluate the expression of PD-1
mucin-domain containing-3 (TIM-3) 1 month to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid
- Secondary Outcome Measures
Name Time Method check point and smoke 1 month to evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Trial Locations
- Locations (2)
Luca Gallelli
🇮🇹Catanzaro, CZ, Italy
AO Materdomini
🇮🇹Catanzaro, Italia, Italy