Guangdong Association of Clinical Trials
试验速览
- 阶段
- 不适用
- 入组人数
- 571
- 主要终点
- Overall survival
研究概览
简要总结
ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.
This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.
详细描述
Primary objective
- To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.
Secondary objectives
- To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
- To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
- To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old.
- •Provision of informed consent prior to any study specific procedures
- •Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- •Have completed lung cancer operation
- •The tumour EGFR gene mutation status test was performed as regular medical practice
排除标准
- •No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
- •Patients withdrew consent for ICAN study;
- •Patients in whose medical record was objected to use the existing data for scientific research
结局指标
主要结局
Overall survival
时间窗: from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.
is defined as the time from the date of operation to date of death. For patients who are still alive, the last date when the patient is known to be alive will be used to determine the censoring date.
次要结局
- Disease free survival(•from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.)