Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis
研究概览
简要总结
This is a prospective diagnostic pilot study to create hypotheses regarding immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy
- •Confirmed diagnosis of non-small cell lung cancer according to ERS guidelines
- •Written informed consent
排除标准
- •Pregnancy and/or lactation
- •Acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.)
- •Any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure)
- •Any medical, psychological or other condition impairing the patient's ability to provide informed consent
结局指标
主要结局
PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis
时间窗: At baseline
Based on all cases where PD-L1 analysis was indicated and sucessful (i.e. giving definite results), the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated: * PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive. * PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive.
PD-L1 Prevalence IHC
时间窗: At baseline
Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
PD-L1 Prevalence ICC
时间窗: At baseline
Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
次要结局
- Tumor Cell Detection in Pleural Effusion(At baseline)
- PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis(At baseline)