Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- CTLA-4 in bronchoalveolar lavage fluid
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• over 18 years of age with suspected diagnosis of pulmonary neoplasia
- •signed the informed consent
排除标准
- •• infected diseases
- •interstitiopathy
- •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
结局指标
主要结局
CTLA-4 in bronchoalveolar lavage fluid
时间窗: 1 month
to evaluate the expression of CTLA-4
PD-L1 in bronchoalveolar lavage fluid
时间窗: 1 month
to evaluate the expression of PD-L1
PD-1 in bronchoalveolar lavage fluid
时间窗: 1 month
to evaluate the expression of PD-1
mucin-domain containing-3 (TIM-3)
时间窗: 1 month
to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid
次要结局
- check point and smoke(1 month)
研究者
Luca Gallelli
Principal Investigator, Clinical Professor
University of Catanzaro