Support for Human Specimen Banking in NCI-Supported Cancer Clinical Trials

描述(由申请人提供)： 儿童肿瘤学小组的组织库有机会在下一个5年的资助周期中，部分通过这项U24申请提供的资源，显著推进儿科癌症研究。从历史上看，COG的银行记录一直很出色，自2003年3月COG成立以来，基于生物标本出版了近300份出版物。COG在这次RFA中的目标是将生物癌症标本采购作为一种接近以人群为基础的努力，类似于儿科癌症临床试验的登记。随着更多的COG治疗变得基于风险，纳入分子参数，这一目标将变得更容易实现，就像我们目前在ALL、神经母细胞瘤和肾母细胞瘤(样本采购率接近临床人群的80%至90%)中看到的那样。软组织肉瘤目前正朝着基于分子的风险分层治疗方向发展。 预计这种向分子/基于风险的治疗的演变将导致在下一个赠款周期中为所有儿科癌症患者至少采购50%的样本。这将产生来自18,000多名患者的约160,000个样本。这一采购将通过复杂的采购工具包、用于标本清点和跟踪的详细生物信息学、全集团教育研讨会(特别是为临床研究助理举办的研讨会)和新技术(虚拟显微镜、组织微阵列)来促进。组织的分子分析将显著改善旨在改善标本采购、储存和交付的质量保证工作。 我们的具体目标如下： 1.建立以人口为基础的儿科癌症患者组织库的收集、储存和质量控制程序。 2.确保儿科组织库标本的适当储存和质量控制程序，以促进杰出的回溯性翻译研究。 3.确保适当管理组织库资源，以方便调查人员获取标本。 4.促进将组织库资源与现有的人口、临床、生物、治疗和结果数据联系起来。 5.利用新兴技术优化有限组织库资源的利用。

DESCRIPTION (provided by applicant): The Tissue Banks of the Children's Oncology Group have an opportunity to significantly advance pediatric cancer research, in part via the resources provided by this U24 application, in the next 5-year grant cycle. Historically, the banking track record of the COG has been outstanding, producing nearly 300 publications based on biologic specimens since the group was created in March 2003. The goal of the COG in this RFA is to approach biologic cancer specimen procurement as an effort that is nearpopulation-based, similar to the enrollment seen with pediatric clinical cancer trials. This goal will become more achievable as more COG therapy becomes risk-based with inclusion of molecular parameters, as we currently see with ALL, neuroblastoma and Wilms tumor (where specimen procurement rates approach 80 to 90 percent of the clinical population). Soft tissue sarcomas are currently evolving toward such molecular-based risk-stratification for treatment purposes. It is anticipated that such an evolution toward molecular/risk-based therapy will lead to at least a 50 percent procurement rate of specimens for all pediatric cancer patients in the next grant cycle. This should produce some 160,000 specimens obtained from more than 18,000 patients. This procurement will be facilitated by sophisticated procurement kits, detailed bioinformatics for specimen inventory and tracking, group-wide educational seminars (particularly for clinical research associates), and new technologies (virtual microscopy, tissue microarrays). Molecular analysis of tissues will significantly improve quality assurance efforts directed toward improving specimen procurement, storage and delivery. Our Specific Aims are as follows: 1. Establish collection, storage and quality control procedures for tissue banking in pediatric cancer patients that are near-population-based. 2. Ensure proper storage and quality control procedures for pediatric tissue bank specimens that promote outstanding retrospective translational research. 3. Ensure proper administration of tissue bank resources to facilitate investigator access to specimens. 4. Promote linkage of tissue bank resources to existing demographic, clinical, biological, treatment and outcome data. 5. Optimize utilization of finite tissue bank resources utilizing emerging technologies.