Multicenter Observational Study for Clinicopathological Characteristics and Clinical Efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Driver gene mutation frequency of Chinese NSCLC patients
研究概览
简要总结
Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.
Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.
By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.
And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.
Study type: Observational
详细描述
Inclusion criteria:
- Female or male, 18 years of age or older；
- Histologically or cytologically proven diagnosis of NSCLC；
- Able to get tumor tissue gene testing results by lung cancer Polymerase Chain Reaction(PCR)panel kit carried out in hospital
- Signed and dated informed consent.
Exclusion criteria:
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results.
Estimated enrollment: 50000 participants.
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
- •Female or male, 18 years of age or older；
- •Histologically or cytologically proven diagnosis of NSCLC；
- •Able to get tumor tissue gene testing results by lung cancer PCR panel kit carried out in hospital；
- •Signed and dated informed consent。
排除标准
- •Combine with other tumor type
- •The investigator judges the situation that may affect the clinical search process and results
结局指标
主要结局
Driver gene mutation frequency of Chinese NSCLC patients
时间窗: 2022
Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.
Clinicopathological characteristics of Chinese NSCLC patients With Rare Driver Gene Mutation
时间窗: 2022
Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world.
Relationship of Clinicopathological characteristics and Rare Driver Gene Mutation of Chinese NSCLC patients
时间窗: 2022
Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients.
次要结局
- Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation(2024)
- Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation(2024)
- Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation(2024)
研究者
Caicun Zhou
Chief Physician
Shanghai Pulmonary Hospital, Shanghai, China