Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Prevalence of KRAS mutation
研究概览
简要总结
Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.
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
- •Age >18 years at the time of the procedure;
- •Suspected advanced, treatment naïve non-squamous NSCLC ;
- •Indication to biopsy for diagnosis and/or molecular profiling;
- •Written informed consent to the study participation.
排除标准
- •Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
- •Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
- •Platelet count <50.000 per μL;
- •Inability or unwillingness to provide a written informed consent.
结局指标
主要结局
Prevalence of KRAS mutation
时间窗: 2 months
Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
次要结局
- Tumor proportion score of PD-L1(2 months)
- Prevalence of cervical/supraclavicular lymph node metastasis(2 months)
- Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK(2 months)
- Predictors of cervical/supraclavicular lymph node metastasis(6 months)