Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 11
- 主要终点
- testing turn around time (in days)
研究概览
简要总结
This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).
详细描述
The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •age 18 years or above
- •newly diagnosed NSCLC
- •written informed consent
- •tumor sample available
排除标准
- •mixed histology of small cell and NSCLC
结局指标
主要结局
testing turn around time (in days)
时间窗: up to 1 month
how long does it take to get the mutation analysis result
次要结局
- demographics(baseline)
- correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status(baseline)
- correlation between family history with regards to cancer and EGFR-mutation status(baseline)