Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- VTE incidence risk evaluation
研究概览
简要总结
This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.
详细描述
VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.
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
- •Age ≥ 18 years at the time of screening.
- •Eastern Cooperative Oncology Group performance status of ≤
- •Written informed consent obtained from the patient.
- •Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system).
- •Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) >12 months.
- •Willingness and ability to comply with scheduled visits and other study procedures.
排除标准
- •History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent.
- •Without signed informed consent.
- •Unwillingness or inability to comply with scheduled visits or other study procedures.
- •Previously diagnosed with VTE before signing informed consent.
结局指标
主要结局
VTE incidence risk evaluation
时间窗: 12 months
Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer.
次要结局
- VTE and overall survival(12 months)
- VTE incidence(12 months)