Immune Checkpoints in COPD

Study Overview
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Brief Summary
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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
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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).

Official Title
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Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer

Conditions
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Lung Cancer, Severe ARDS, Asthma, Copd

Intervention / Treatment
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* Other: check immune check points


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • over 18 years of age with suspected diagnosis of pulmonary neoplasia signed the informed consent Exclusion Criteria: • 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy never smokers<br>Clinical evaluation of immune check points expression. A prospective study | Other: check immune check points<br>* we will evaluate the expression of immune check points<br>|
| Smokers with normal lung function<br>evaluation of immune check points expression | Other: check immune check points<br>* we will evaluate the expression of immune check points<br>|
| Lung cancer<br>evaluation of immune check points expression | Other: check immune check points<br>* we will evaluate the expression of immune check points<br>|
| COPD<br>evaluation of immune check points expression | Other: check immune check points<br>* we will evaluate the expression of immune check points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 in bronchoalveolar lavage fluid | to evaluate the expression of PD-L1 | 1 month | 
| CTLA-4 in bronchoalveolar lavage fluid | to evaluate the expression of CTLA-4 | 1 month | 
| mucin-domain containing-3 (TIM-3) | to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid | 1 month | 
| PD-1 in bronchoalveolar lavage fluid | to evaluate the expression of PD-1 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| check point and smoke | to evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic diseases