CTRI/2021/07/035023已完成不适用
A Multicountry, Multicentre, Non-interventional, Prospective Study toDetermine the Prevalence of EGFR Mutations in Patients With Early-stage,Surgically Resected, Non-squamous, Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 9
- 主要终点
- Histology,
研究概览
简要总结
This prospective, sequential non-interventional study aims to determine the prevalence and nature of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC. This study will also determine the surgical management, surgical outcome, and neoadjuvant and adjuvant therapies prescribed for early-stage disease.
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
- •Adult male or female patients ≥18 years old or ‘adults’ according to age of majority as defined by the local regulations
- •Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
- •Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeksa
- •Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
- •Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC.
排除标准
- •Histology of the tumour is considered not to be of primary lung in origin
- •Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation.
结局指标
主要结局
Histology,
时间窗: One day
Pathologic stage, Age, Gender
时间窗: One day
Tobacco smoking, Ethnicity, Family history of lung cancer in first-degree relative, Geographical location.
时间窗: One day
Overall proportion of patients with EGFRm
时间窗: One day
• Proportion of EGFRm by the following subgroups:
时间窗: One day
次要结局
- Proportion of patients with the following EGFRm types:(Exon19 deletions, Exon21 L858R)
研究者
研究点 (9)
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