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

在 NCI 支持的癌症临床试验中支持人体样本库

• 批准号: 8260001
• 负责人: NILSA DEL CARMEN RAMIREZ MILAN
• 金额: $ 37.85万
• 依托单位: NATIONAL CHILDHOOD CANCER FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-03 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8260001
• 关键词: Bioinformatics; Biological; Cancer Patient; Childhood; Children' s Oncology Group; Clinical; Clinical Research Associate; Clinical Treatment; Clinical Trials; Collection; Data; Emerging Technologies; Enrollment; Ensure; Equipment and supply inventories; Evolution; Funding; Goals; Grant; Human; Lead; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Microscopy; Molecular; Molecular Analysis; Molecular Profiling; Nephroblastoma; Neuroblastoma; Patients; Phase; Population; Procedures; Publications; Quality Control; Research Personnel; Resources; Risk; Specimen; Stratification; Tissue Banking; Tissue Banks; Tissue Microarray; Tissues; Translational Research; Treatment outcome; Work; anticancer research; base; improved; new technology; patient population; population based; quality assurance; sarcoma; soft tissue; treatment trial; virtual

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.

描述（由申请人提供）： 儿童肿瘤学组的组织库有机会在下一个 5 年资助周期中显着推进儿科癌症研究，部分通过 U24 申请提供的资源。从历史上看，COG 的银行记录一直非常出色，自 2003 年 3 月成立以来，已出版了近 300 份基于生物样本的出版物。COG 在本次 RFA 中的目标是将生物癌症样本采购作为一项努力，接近基于人群，类似于儿科临床癌症试验的入组情况。随着越来越多的 COG 治疗变得基于风险并包含分子参数，这一目标将变得更容易实现，正如我们目前在 ALL、神经母细胞瘤和肾母细胞瘤（其中样本获取率接近临床人群的 80% 至 90%）中所看到的那样。软组织肉瘤目前正在朝着这种基于分子的风险分层的治疗目的发展。 预计这种向基于分子/风险的治疗的发展将导致在下一个拨款周期中所有儿科癌症患者的标本采购率至少达到 50%。这应该会产生从 18,000 多名患者身上获取的约 160,000 个样本。复杂的采购工具包、用于样本库存和跟踪的详细生物信息学、集团范围内的教育研讨会（特别是针对临床研究人员）和新技术（虚拟显微镜、组织微阵列）将促进这种采购。组织的分子分析将显着改善质量保证工作，从而改善样本采购、储存和交付。 我们的具体目标如下： 1. 建立接近人群的儿童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，以促进杰出的回顾性转化研究。 3. 确保组织库资源的适当管理，以方便研究者获取标本。 4. 促进组织库资源与现有人口、临床、生物、治疗和结果数据的联系。 5. 利用新兴技术优化有限组织库资源的利用。