Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 主要终点
- Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
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 identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.
详细描述
OBJECTIVES:
- To evaluate the frequency of ATP-binding cassette, sub-family G (WHITE), member 2 (ABCG2), met proto-oncogene (hepatocyte growth factor receptor) (c-MET), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) polymorphisms or mutations in this study population and the predictiveness of these polymorphisms on survival, time to progression, response rate, and toxicities.
OUTLINE: Archived tumor tissue and peripheral blood mononuclear cells are analyzed for the frequency of ABCG2, c-MET, and K-ras polymorphisms or mutations by polymerase chain reaction (PCR). Results are then correlated with patients' clinical outcomes and toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
时间窗: 1 year
The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples
时间窗: 1 year
Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test
时间窗: 1 year
Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests
时间窗: 1 year
次要结局
未报告次要终点