Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 主要终点
- Mesenchymal and epithelial markers
研究概览
简要总结
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.
PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.
详细描述
OBJECTIVES:
- Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
- Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
- Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
- Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.
OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.
PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 120 Years（Child, 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
Mesenchymal and epithelial markers
时间窗: 1 month
Mesenchymal and epithelial markers
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)
时间窗: 1 month
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
时间窗: 1 month
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
时间窗: 1 month
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
次要结局
未报告次要终点