Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ALK mutation by tissue assay.
研究概览
简要总结
Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.
详细描述
The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.
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
- 是
入选标准
- •Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
- •Age of 18 years or older.
- •Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
- •Participants must have hemoglobin > 10 mg/dL.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Hepatitis (all types) in patient's medical record
- •HIV documented in patient's medical record
- •Hemoglobin < 10 mg/dL
- •Less than 18 years of age
- •Histologically confirmed NSCLC Stage I-IIIA
- •Tested negative for the presence of EML4-ALK and T790M EGFR on tissue
结局指标
主要结局
ALK mutation by tissue assay.
时间窗: Two years
Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
T790M EGFR mutation by tissue assay
时间窗: Two years
Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
次要结局
未报告次要终点