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: 7602986
• 负责人: GREGORY H REAMAN
• 金额: $ 119.56万
• 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/7602986
• 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）： 儿童肿瘤学小组的组织库有机会在下一个5年的赠款周期中，部分通过该U24应用程序提供的资源来大大推进小儿癌症研究。从历史上看，COG的银行业务记录非常出色，自2003年3月创建该组以来，基于生物学标本生产了近300个出版物。该RFA中COG的目标是将基于人群的生物癌标本采购作为基于人群的努力，类似于与Pediatric Clinical Clinical Canlic Callical Cluinical Cancer callical Callical Cancer trialical Chinical Chinical Callical Charigal Chinical Charigation。正如我们目前所看到的，神经母细胞瘤和威尔姆斯肿瘤（标本采购率接近80至90％的临床人群），随着更多的COG疗法成为基于风险的，这一目标将变得更加可实现。软组织肉瘤目前正在发展为治疗目的的这种基于分子的风险分层。 预计在下一个赠款周期中，对所有儿科癌症患者的标本采购率至少将导致至少50％的采购率。这将产生约18,000多名患者获得的160,000个标本。这项采购将通过复杂的采购套件，用于标本库存和跟踪的详细生物信息学，整个群体范围的教育研讨会（尤其是针对临床研究协会）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着改善针对改善标本采购，存储和输送的质量保证工作。 我们的具体目的如下： 1。在小儿癌症患者中建立收集，存储和质量控制程序，以基于人群的小儿癌症患者。 2.确保针对小儿组织库标本的适当存储和质量控制程序，以促进出色的回顾性转化研究。 3.确保正确管理组织库资源，以促进研究人员使用标本。 4。促进组织库资源与现有人口，临床，生物学，治疗和结果数据的联系。 5。优化利用新兴技术的有限组织库资源。