A Randomized Controlled Study of Single Port Tubeless VATS for the Evaluation of Qualified Rate of Biopsy for Second-generation Tibial Specimens in Patients With Advanced NSCLC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 主要终点
- Qualified Rate of Biopsy for Second-generation Tibial Specimens
研究概览
简要总结
The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent is obtained
- •Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy
排除标准
- •History of other malignant tumors.
- •The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
- •History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process
结局指标
主要结局
Qualified Rate of Biopsy for Second-generation Tibial Specimens
时间窗: up to 2 years
Different biopsy methods (single-port tubeless VATS biopsy vs CT-guided fine-needle aspiration biopsy) are used to evaluate the qualification rate of samples obtained for NGS testing
次要结局
- Tumor Content Size(up to 2 years)
- Overall Survival(up to 2 years)
- Gene Mutation Rate(up to 2 years)
- TMB detection situation(up to 2 years)
- Drug sensitive mutation detection rate(up to 2 years)
- Detection of PD-L1 expression(up to 2 years)
- Correlation between tumor cell content and detection rate of sensitive mutations(up to 2 years)
- Perioperative complications(up to 2 years)
- Postoperative patient experience score(up to 2 years)
- Usage rate of targeted drug(up to 2 years)
- Postoperative MRD detection(up to 2 years)
- Success rate of enrollment(up to 2 years)
- Progression Free Survival(up to 2 years)
研究者
Jianxing He
Prof.
The First Affiliated Hospital of Guangzhou Medical University