CORRELATIVE LABORATORY AND INNOVATIVE CLINICAL TRIALS

国家外科辅助乳腺和肠道项目（NSABP）是一个NCI- 资助的临床合作小组，进行了大规模的临床 评价原发性乳腺癌和肠道癌治疗方法的试验 癌在所有试验中实施了程序，以1）尽量减少 不合格率，2）允许对所有患者进行中心病理学审查，3） 保持良好的后续报告，数据拖欠率低，以及4） 提供对方案依从性的持续医学审查。就两项 NSABP辅助治疗淋巴结阴性乳腺癌的试验 证实了无病生存率的改善;然而，所有淋巴结阴性 患者不能从辅助治疗中获益，“更好”的标记物是 需要更准确地确定那些应该获得 特殊疗法尽管有许多标记物被报道为 价值在这样的努力，没有人被评估和比较， 建立的标记或与新的标记在同一群体中， 患者该提案将允许通过以下方式检索肿瘤标本： 参与这两项NSABP试验的患者的研究者。一旦 获得这些标本，测定多个新标记物， 将有可能在这个控制良好，仔细表征， 前瞻性随访患者人群。标记物结果分析 患者结局将独立于标记物进行 决心。

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.