NSABP Biological Specimen Banks

描述（由申请人提供）：在过去的50年里，NSABP已经将10万多名诊断为乳腺癌或结直肠癌的患者随机分配到临床试验中。基于通过这些试验中测试的治疗方式的多个演变步骤实现的增量获益，患者结局总体上已实现显著改善。然而，这种方法也意味着一些没有从各种干预措施中受益的患者存在严重的过度治疗，这些干预措施现在已成为添加新药物的传统治疗的一部分。需要开发可靠的预后和预测测试，以实现更个性化的治疗目标。由于伦理原因，一旦新方案的有效性得到证明，就不能再次进行试验，因此NSABP进行的历史试验的存档肿瘤组织块为试图开发此类测试的研究人员提供了重要资源。NSABP病理组织库分部的NSABP生物标本库收藏了来自87，000多名患者的肿瘤组织标本，并作为科学界的开放资源，为新的预后或预测测试的开发和临床验证提供组织。根据科学价值，向学术界和私营部门的调查人员提供组织标本。私营部门与该银行合作开发的基于多基因表达的预后检测（OncotypeDx）已成为美国激素受体阳性淋巴结阴性乳腺癌临床管理的标准。全基因组基因表达分析和福尔马林固定石蜡包埋块突变谱分析方法的内部开发和/或优化进一步提高了NSABP生物标本库的价值。

DESCRIPTION (provided by applicant): The NSABP has randomized more than 100,000 patients with diagnoses of breast or colorectal cancers into clinical trials during the past 50 years. Based on incremental benefit achieved through multiple evolutionary steps of treatment modalities tested in those trials, significant improvement in patient outcomes has been achieved overall. However, this approach also means that there has been significant over-treatment of some patients who did not benefit from the various interventions, which now have become part of legacy treatments to which newer agents are added. Development of reliable prognostic and predictive tests is required to deliver the goal of more personalized treatment. Since, for ethical reasons, trials cannot be conducted again once the efficacy of newer regimens is demonstrated, archived tumor tissue blocks from historical trials conducted by the NSABP provide an essential resource to investigators who are trying to develop such tests. The NSABP Biospecimen Bank at the NSABP Division of Pathology Tissue Bank houses tumor-tissue specimens from more than 87,000 patients and serves as an open resource to the scientific community to provide tissues for development and clinical validation of new prognostic or predictive tests. Tissue specimens are provided to investigators from both academia and the private sector on the basis of scientific merit. A multi-gene expression based prognostic test (OncotypeDx) developed in a collaboration between the private sector and the bank has become a standard in clinical management of hormone receptor positive node negative breast cancer in the United States. In-house development and/or optimization of methods for whole-genome gene-expression analyses and mutation profiling of formalin-fixed, paraffin-embedded blocks further enhances the value of the NSABP Biospecimen Bank.