Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Idylla EGFR Mutation Test
研究概览
简要总结
This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.
详细描述
This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients diagnosed with primary lung cancer
- •Data from primary diagnosis must be included in pathology report or data entry.
- •Detailed pathology report included for all samples
排除标准
- •Limited or no tissue available
- •Only tissue available is from fine needle aspiration
- •Tissue blocks older than 5 years old
结局指标
主要结局
Idylla EGFR Mutation Test
时间窗: Retrospective tissue samples no longer than 5 years old
The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.
次要结局
未报告次要终点
研究者
Anthony Magliocco
Principal Investigator
Protean BioDiagnostics