A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 897
- 试验地点
- 1
- 主要终点
- the concordance of T790M mutation testing between the test in central and local labs
研究概览
简要总结
The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.
详细描述
This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.
研究设计
- 研究类型
- Observational
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
- •Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
- •Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
- •Patients who have progressed following prior therapy with an EGFR-TKI agent.
- •Patients who consent to provide tumour tissue and/or blood.
排除标准
- •Patients who disagree to participate this study.
- •Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
结局指标
主要结局
the concordance of T790M mutation testing between the test in central and local labs
时间窗: within 1 -14 days after enrolled
Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
次要结局
- The Positive predictive value of each platform based on the local lab plasma testing(within 1 -14 days after enrolled)
- The prevalence rate of T790M mutation based on the central lab testing(within 1 -14 days after enrolled)
- The sensitivity of each platform based on the local lab plasma testing(within 1 -14 days after enrolled)
- The Negative predictive value of each platform based on the local lab plasma testing(within 1 -14 days after enrolled)
- The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing(within 1 -14 days after enrolled)
- Rare EGFR mutation prevalence rate(within 1-14 days after enrolled)
- The Specificity of each platform based on the local lab plasma testing(within 1 -14 days after enrolled)
- The Concordance of each platform based on the local lab testing(within 1 -14 days after enrolled)