Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer: A Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This multi-center, prospective, observational study aim to construct a comprehensive model, integrating common clinical pathological parameters, radiographic features and multi-omics data, for assessing the risk and prognosis of brain metastasis in NSCLC. This model is intended to address the following clinical needs: (1) Identify patients at high risk of brain metastasis; (2) Optimize the combined strategies of local and systemic treatments; (3) Predict the survival outcomes of patients with brain metastases from NSCLC and provide evidence-based support for individualized treatment decisions.
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
- •Pathologically confirmed non-small cell lung cancer;
- •Age≥18 years old;
- •KPS score≥70;
- •Complete systemic imaging (including brain MRI) before treatment initiation, including contrast-enhanced MRI of the brain;
- •Receiving standard treatment;
- •Informed consent of the patient.
排除标准
- •Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- •Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of - Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;
- •Pregnant or lactating women.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 2 years
The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.
次要结局
- Intracranial Progression-Free Survival (iPFS)(2 years)
- Overall Survival (OS)(2 years)