A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.
详细描述
Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.
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
- •Participant aged 18 or above, and gender unrestricted
- •Individual with pathologically diagnosed lung cancer
排除标准
- •Patients with concomitant other tumors
- •Individual with severe cardiopulmonary insufficiency and hypoproteinemia
- •Women who were pregnant and were during their lactation
结局指标
主要结局
Progression-free survival (PFS)
时间窗: through the whole study period, an average of 3 year
PFS refers to the time from initial treatment to the time of disease progression or death
Tumor Mutational Burden (TMB)
时间窗: halfway of the study, an average of 1.5 year
TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases
次要结局
- Other biomarkers(halfway of the study, an average of 1.5 year)
- Overall survival (OS)(through the whole study period, an average of 3 year)
- Clonality(halfway of the study, an average of 1.5 year)
研究者
Lu Shun
Chief physician
Shanghai Chest Hospital