Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Incremental actionable targets
研究概览
简要总结
Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 of age
- •Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
- •Stage IV disease
- •Sufficient FFPE tumour tissue for OCCP testing
- •Performance status 0-2
- •Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
- •Prognosis > 6 months
- •Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
排除标准
- •● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy
结局指标
主要结局
Incremental actionable targets
时间窗: 8-12 weeks from Oncomine Comprehensive Assay testing
Calculate the number of incremental actionable targets identified by the Oncomine Comprehensive Assay compared to current standard of care molecular profiling (EGFR, ALK) in patients with stage IV NSCLC.
Number of clinical trial opportunities
时间窗: 1 year from Oncomine Comprehensive Assay testing
Compile the number of clinical trial opportunities that patients with stage IV NSCLC would be eligible for based on targets identified by the Oncomine Comprehensive Assay compared to standard of care molecular profiling (EGFR, ALK).
次要结局
- Patient willingness-to-pay(To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).)
- Financial feasibility(To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).)
- Test turnaround time(To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).)