CHILDHOOD CANCER DATA INITIATIVE: CLINICAL TRIAL SPECIMEN MOLECULAR CHARACTERIZATION (CTSMC) PROGRAM

国家癌症研究所(NCI)儿童癌症数据倡议(CCDI)专注于收集、分析和共享数据的迫切需要，以应对儿童、青少年和年轻人(AYA)的癌症负担。该倡议支持儿童癌症研究，旨在使研究人员更容易向美国每年约1.6万名被诊断患有癌症的儿童和青少年学习。 通过CCDI，NCI寻求加强儿童癌症数据的收集，确保数据可供访问，从而激励癌症研究社区为患有癌症的儿童开发新的治疗方法。更具体地说，为了增加数据的使用和共享，以追求儿童癌症防治的进展，CCDI的目标是： ·最大限度地利用每一个机会来改善癌症儿童的治疗和结果 ·建立互联数据基础设施，以共享来自多个来源的儿童癌症数据 ·确定让数据更好地为患者、临床医生和研究人员工作的机会 ·开发和改进从数据中提取知识的工具和方法 癌症临床试验通过NCI资助的儿科早期临床试验网络(PEP-CTN)和儿童肿瘤学小组(COG)为儿童和AYA提供。通过这些临床试验，美国和世界各地的儿科和Aya癌症患者可以获得最先进的治疗方法，并定期从这些临床试验登记的患者身上收集样本。NCI支持的其他研究收集了儿科和Aya癌症患者的患者数据和样本，以更好地了解这些疾病并找到潜在的治疗方法。 来自患有癌症的儿童和AYA的组织样本极其有限，是一种宝贵的资源。从这些标本中产生的数据往往是零散的，研究人员和肿瘤学团队无法广泛获得。下一代测序技术越来越多地可用于快速对DNA和RNA进行测序，并识别与不同肿瘤类型和疾病阶段相关的基因突变、基因改变和全球基因表达的变化。其他用于分子表征的补充技术，如代谢组学、表观基因组学和蛋白质组学的分析，以及更成熟的IHC或FISH分析，现在也可以使用。阿特。1，75N91019D00024，任务单75N91020F00021，至2023年4月13日修改 第3页 最大限度地利用从NCI支持的临床试验和研究中收集的儿童和Aya癌症样本，并使结果数据广泛用于研究，将对我们预防、诊断和治疗这一患者群体的能力产生深远影响，并可以作为改进癌症类型和其他疾病连续序列数据使用的模式。

The National Cancer Institute (NCI) Childhood Cancer Data Initiative (CCDI) focuses on the critical need to collect, analyze, and share data to address the burden of cancer in children, adolescents, and young adults (AYAs). The initiative supports childhood cancer research and aims to make it easier for researchers to learn from each of the approximately 16,000 children and adolescents diagnosed with cancer in the United States each year. Through the CCDI, NCI seeks to enhance data collection for childhood cancers, ensure that data is accessible, and thereby incentivize the cancer research community to develop new treatments for children with cancer. More specifically, to increase data use and sharing in pursuit of progress against childhood cancers, the CCDI aims to: • Maximize every opportunity to improve treatments and outcomes for children with cancer • Build a connected data infrastructure to enable sharing of childhood cancer data from multiple sources • Identify opportunities to make data work better for patients, clinicians, and researchers • Develop and enhance tools and methods to extract knowledge from data Cancer clinical trials are available for children and AYAs through the NCI-funded Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Children’s Oncology Group (COG). Through these clinical trials, pediatric and AYA cancer patients across the U.S. and around the world can access state-of-the-art therapies, and specimens are routinely collected from patients enrolled across these clinical trials. Other NCI-supported studies collect patient data and specimens from pediatric and AYA cancer patients to better understand these diseases and find potential treatments. Tissue samples from children and AYAs with cancer are critically limited and a valuable resource. Data generated from these specimens are often fragmented and not broadly available to researchers and oncology teams. Next-generation sequencing technologies are increasingly available to quickly sequence DNA and RNA and identify gene mutations, genetic alterations, and changes in global gene expression that are associated with different tumor types and stages of disease. Other complementary technologies for molecular characterization, such as assays for metabolomics, epigenomics, and proteomics as well as more established IHC or FISH assays, are also now accessible. Att. 1, 75N91019D00024, Task Order 75N91020F00021, through modification 6. 04/13/2023 Pg 3 Maximizing the use of childhood and AYA cancer specimens collected on NCI-supported clinical trials and studies and making the resulting data broadly available for research will have a profound impact on our ability to prevent, diagnose, and treat this patient population, and can serve as a model for improving the use of data across cancer types and other disease continuums.