CTRI/2018/10/016221已完成不适用
A multi-country, multi-centre, observational, retrospective study to revealthe patient characteristics, disease burden, treatment patterns and patientjourney of stage III non-small-cell lung cancer patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 19
- 主要终点
- III NSCLC diagnosis (index
研究概览
简要总结
This large multinational, non-interventional study (NIS), will retrospectively collect data derived from established medical records over a period of up to approximately 6 years (2013 to 2018), building a platform to capture and consolidate information on treatment patterns, Overall Survival (OS) and treatment effectiveness outcomes in the real-world setting.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations
- •Adult male or female (18 years old or according to age of majority as defined by local regulations)
- •First ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including small cell lung cancer [SCLC] and NSCLC) in the patient’s medical records
- •Primary diagnosis of stage III NSCLC, confirmed by pathology, between 01 January 2013 and 31 December 2017
- •Available medical records at the participating site reflect at least 9 months of follow-up from the index date (unless patient died within the first 9 months of diagnosis).
排除标准
- •Patients with a concomitant cancer at the time of diagnosis of stage III NSCLC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms.
- •A cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
- •Patients initially diagnosed with stage I-II NSCLC who have progressed to stage III.
结局指标
主要结局
III NSCLC diagnosis (index
时间窗: 9 months
cause.
时间窗: 9 months
Overall survival (OS)
时间窗: 9 months
The length of time from stage
时间窗: 9 months
date) or time of therapy
时间窗: 9 months
initiation to death due to any
时间窗: 9 months
次要结局
- Progression-free survival((PFS)The length of time from time of)
研究者
研究点 (19)
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