Study of Epithelial Growth Factor Receptor Mutations in Tumor Specimens and Blood Samples From Patients With Non-Small Cell Lung Cancer Enrolled on Clinical Trial CASE-2507
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS)
研究概览
简要总结
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
- Investigate EGFR DNA copy-number changes.
- Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.
OUTLINE: This is a multicenter study.
DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS)
时间窗: At the time of the second biopsy or surgical procedures
Difference of PFS between those with and without T790M mutation
时间窗: At the time of the second biopsy or surgical procedures
Difference of clinical response rate between T790M mutation statuses
时间窗: At the time of the second biopsy or surgical procedures
Predictive value of mutation status on clinical response
时间窗: At the time of the second biopsy or surgical procedures
Association between T790M mutation and baseline clinical-pathological factors and smoking status
时间窗: At the time of the second biopsy or surgical procedures
次要结局
未报告次要终点