CORRELATIVE LABORATORY AND INNOVATIVE CLINICAL TRIALS

国家外科辅助乳肠计划(NSABP)是一项NCI-- 资助的临床合作小组进行了大规模的临床 评价治疗原发性乳腺和肠道疾病的临床试验 癌症。所有试验都实施了程序，以将1)最小化 不合格率，2)允许对所有患者进行中央病理检查，3) 以较低的数据拖欠率维护良好的后续报告，以及4) 提供对协议合规性的持续医学审查。两项研究的结果 NSABP在辅助治疗淋巴结阴性乳腺癌方面的试验 显示出改善的无病存活率；然而，所有的结节阴性 患者不能从辅助治疗中受益，而“更好”的标记物 需要更准确地识别哪些人应该获得 特殊的治疗方法。尽管有大量的标记被报道为 在这种努力中的价值，没有一个被评估和比较 已建立的标记或在同一群体中具有较新的标记 病人。这项提议将允许通过以下方式检索肿瘤样本 来自患者的研究人员参与了这两项NSABP试验。一次 这些标本的获得，确定了多个新的标记 将有可能在这一良好的控制，仔细的特点， 前瞻性跟踪观察患者群体。评分员成绩分析 可以独立于标记物进行检查 决定。

The National Surgical Adjuvant Breast and Bowel Project (NSABP) is an NCI-- funded clinical cooperative group that has conducted large-scale clinical trials evaluating therapies in the treatment of primary breast and bowel cancer. Procedures have been implemented across all trials to 1) minimize ineligibility rates, 2) allow central pathology review of all patients, 3) maintain good follow-up reporting with low data-delinquency rates, and 4) provide ongoing medical review of protocol compliance. The results of two NSABP trials in the adjuvant treatment of node-negative breast cancer have demonstrated an improved disease-free survival; however, all node-negative patients do not benefit from adjuvant therapy, and "better" markers are needed to more accurately identify those individuals who should receive a particular therapy. Although numerous markers have been reported to be of value in such an effort, none have been evaluated and compared with established markers or with newer markers in the same population of patients. This proposal will allow for the retrieval of tumor specimens by the investigators from patients entered into these two NSABP trials. Once these specimens are obtained, the determination of multiple new markers will be possible in this well-controlled, carefully characterized, prospectively followed patient population. The analysis of marker results with patient outcome would be performed independently of the marker determinations.