Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery: A Retrospective Multi-center Study (EarlyLC-RW)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Disease-free survival(DFS)
研究概览
简要总结
The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of early-stage lung cancer patients who have received surgery using the real-world data. The main questions it aims to answer are:
- What is the best surgical strategy for patients with early-stage lung cancer?
- What are the risk factors for early-stage lung cancer? Participants will receive surgery and the study will analyze the real-world data.
详细描述
This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of surgical interventions in early-stage lung cancer patients, utilizing real-world data.
Central to this investigation are two key questions:
- What is the optimal surgical approach for managing early-stage lung cancer?
- What are the primary risk factors associated with the development of early-stage lung cancer? Participants will undergo surgical procedures, and through rigorous analysis of real-world data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85;
- •Did not receive neoadjuvant therapy before surgery;
- •No history of radiation therapy;
- •Eastern Cooperative Oncology Group (ECOG) score is 0-1;
- •Have complete clinically relevant information including imaging data;
- •All patients underwent relevant preoperative examinations;
- •Stage I lung cancer (International Association for the Study of Lung Cancer/The Union for International Cancer Control staging eighth edition);
排除标准
- •Have previously received chemotherapy, radiotherapy and other anti-tumor therapy;
- •Data loss and error in medical records due to human/objective reasons.
结局指标
主要结局
Disease-free survival(DFS)
时间窗: Defined as the time from the date of surgery until the date of first documented progression or death (by any cause in the absence of recurrence), whichever came first, assessed up to 10 years.
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
次要结局
- Overall Survival (OS)(From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 10 years.)
- 5-year Overall Survival (overall survival) Rate(From date of surgery until date of death due to any cause. Assessed at 5 years.)
- Patterns of Relapse(Within 10 years after surgery)
- Perioperative Complication rate(Within 6 months after surgery)