Validation of Molecular Prognostic Tests in NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.
SECONDARY OBJECTIVES:
I. To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.
II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage specific prognostic classifiers.
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
- •Registration to CALGB-140202
- •The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
- •All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
- •Tumor specimens need to have 40% tumor content to be included
排除标准
- 未提供
结局指标
主要结局
Recurrence
时间窗: up to 36 months
次要结局
- Disease-free survival(up to 36 months)
- Overall survival(up to 36 months)
- Cancer specific survival(Up to 36 months)
- Probability of death due to other causes(up to 36 months)