Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.
详细描述
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
5-year overall survival
时间窗: 5 years
The event is defined as the death due to any causes.
次要结局
- 10-year overall survival(10 years)
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University