Children's Oncology Group Statistics and Data Center

儿童肿瘤学组统计和数据中心

• 批准号: 10667275
• 负责人: TODD A ALONZO
• 金额: $ 20.28万
• 依托单位: PUBLIC HEALTH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10667275
• 关键词: Adolescent; Area; Biological Specimen Banks; Blood; Bone Marrow Transplantation; Brain Neoplasms; Canada; Cancer Center; Catalogs; Child; Childhood; Clinical; Clinical Data; Computer software; Country; Data; Data Collection; Data Commons; Diagnosis; Disease; Drug Combinations; Enrollment; Ensure; Funding; Grant; International; Libraries; Malignant Childhood Neoplasm; Manuscripts; Medidata; Molecular; National Cancer Institute; Outcome; Parents; Participant; Patients; Pediatric Hospitals; Pediatric Oncology Group; Phase; Preparation; Procedures; Process; Protocols documentation; Relapse; Reporting; Research; Research Personnel; Resources; Site; Soft tissue sarcoma; Solid Neoplasm; Source; Specimen; Standardization; Time; Transplantation; Tumor Tissue; Universities; Workload; anticancer research; archive data; archived data; data archive; data centers; data dictionary; data exchange; data harmonization; data standards; flexibility; improved; international center; migration; pediatric patients; programs; rare cancer; sample collection; statistics; telework; tumor; young adult

CIBMTR Linkage COG sites submit clinical data about transplants to the Center for International Blood & Marrow Transplant Research (CIBMTR). It would be beneficial for COG to have access to the wealth of patient-level clinical transplant data obtained by the CIBMTR. ComboMATCH ComboMATCH will be one of the successor trials to MATCH which will focus on drug combinations. COG will develop a cassette of treatment sub-studies for pediatric and young adult patients. Harmonization and transfer of data to the Pediatric Cancer Data Commons International pediatric cancer data commons (PCDC) consortiums have been developed for several disease areas. COG statisticians will harmonize data from completed COG trials to align with the data dictionaries and then transfer the data to the PCDC. Molecular Characterization Protocol The NCI is sponsoring program of centralized molecular characterization for pediatric patients with brain tumors, soft tissue sarcomas, and selected rare cancers, using Project: EveryChild (APEC14B1) as the mechanism for enrollment, specimen collection, and clinical annotation. Molecular Characterization MCI Reporting The Molecular Characterization Initiative (MCI) provides state-of-the-art molecular characterization at the time of diagnosis that helps participants and doctors select the best and most appropriate treatment. Project: EveryChild (APEC14B1) is used as the mechanism for enrollment, specimen collection, and clinical annotation. MCI data collected via APEC14B1 will be transferred to the NCI for reporting purposes. Other Operational Needs Funds are requested to assist with expenses for Medidata RAVE academic professional support, Statistical Software, and Supplies for Teleworking Optimization. Phase III NCNT/NCORP Data Archive Data from phase 2 and 3 studies completed by COG are available to researchers outside of COG through the NCTN/NCORP Data Archive. In this grant year data will be submitted to the NCTN/NCORP Data Archive for manuscripts summarizing results several studies. Project EveryChild (PEC) Build Optimization The data collected on Project:EveryChild will be a major source of data for the National Cancer Institute’s (NCI) Childhood Cancer Data Initiative (CCDI) Global Data Commons. COG has developed a parent/child study builds plan which would allow for flexibility in form changes and minimization of the impact of smaller focused child study migrations, greatly reducing the workload and url resources required for disease specific requested changes. RAVE Global Library COG in partnership with Westat has developed processes and procedures to catalogue and standardize the clinical data within and across COG studies, by disease area, in preparation for loading into the CCDI Global Data Commons. The standardized data collection will become the basis for a global library of eCRFs in Medidata Rave which will ensure the usage of the standards and improve efficiencies in study build and analysis. Tumor Specimens from Patients at Relapse COG solid tumor committees have a desire to increase biospecimen banking of tumor tissue obtained at relapse, with clinical annotation for future research. Funding will be used to enhance the volume and quality of tumor specimens obtained at relapse, as well as improve the characterization, stability, and utility of already banked biospecimens.

CIBMTR链接 COG研究中心向国际血液和骨髓中心提交有关移植的临床数据 移植研究（CIBMTR）。这将是有益的COG有机会获得的财富， CIBMTR获得的患者水平临床移植数据。 组合匹配 ComboMATCH将是MATCH的后续试验之一，其重点是药物 组合。COG将为儿童和年轻成人开发治疗子研究的盒式磁带 患者 协调并向儿科癌症数据共享区传输数据 国际儿科癌症数据共享（PCDC）联盟已经开发， 几个疾病领域。COG统计人员将协调已完成COG试验的数据， 然后将数据传输到PCDC。 分子表征方案 NCI正在赞助儿科患者的集中分子表征项目 脑肿瘤，软组织肉瘤，和选定的罕见癌症，使用项目：EveryChild （APEC 14 B1）作为入组、标本采集和临床注释的机制。 分子表征MCI报告 分子表征计划（MCI）提供了最先进的分子表征技术， 诊断时的特征，帮助参与者和医生选择最好的， 最合适的治疗。项目：EveryChild（APEC 14 B1）被用作 入组、标本采集和临床注释。通过APEC 14 B1收集的MCI数据将 转移到NCI用于报告目的。 其他业务需要 申请资金用于支付Medidata RAVE学术专业人员的费用 支持、统计软件和远程办公优化用品。 III期NCNT/NCORP数据存档 COG完成的2期和3期研究的数据可供COG以外的研究人员使用 通过NCTN/NCORP数据存档。在本补助年度，数据将提交给 NCTN/NCORP数据存档，用于总结几项研究结果的手稿。 Project EveryChild（PEC）构建优化 “每个孩子”项目收集的数据将成为全国癌症调查的主要数据来源。 儿童癌症数据倡议（CCDI）全球数据共享。COG有 制定了父母/子女研究构建计划，该计划将允许形式变化的灵活性， 最大限度地减少较小的重点儿童研究迁移的影响， 疾病特定请求的更改所需的工作量和URL资源。 RAVE全球图书馆 COG与Westat合作制定了流程和程序， 按疾病领域标准化COG研究内和研究间的临床数据， CCDI Global Data Commons数据共享标准化的数据收集将成为 Medidata Rave中全球eCRF库的基础， 标准，并提高研究构建和分析的效率。 复发患者的肿瘤标本 COG实体肿瘤委员会希望增加肿瘤组织的生物标本库 在复发时获得，具有用于未来研究的临床注释。资金将用于 提高复发时获得的肿瘤标本的数量和质量， 已经储存的生物样本的表征、稳定性和实用性。