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联动 COG 站点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) 能够获得 COG 的财富将是有益的。 CIBMTR 获得的患者级临床移植数据。 连击赛 ComboMATCH 将是 MATCH 的后续试验之一，重点关注药物 COG 将为儿童和年轻人开发一系列治疗子研究。 患者。 数据的协调和传输到儿科癌症数据共享 国际儿科癌症数据共享 (PCCDC) 联盟的成立是为了 多个疾病领域的 COG 统计学家将协调已完成的 COG 试验的数据以进行调整。 与数据字典，然后将数据传输到 PCCDC。 分子表征方案 NCI 正在赞助儿科患者的集中分子表征计划 使用项目：EveryChild 治疗脑肿瘤、软组织肉瘤和选定的罕见癌症 (APEC14B1) 作为登记、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) 提供最先进的分子表征 诊断时的表征，帮助参与者和医生选择最好的和 最合适的治疗方法：EveryChild (APEC14B1) 被用作机制。 通过 APEC14B1 收集登记、样本采集和临床注释。 出于报告目的而转移至 NCI。 其他运营需求 需要资金来协助 Medidata RAVE 学术专业人士的费用 支持、统计软件和远程办公优化用品。 第三阶段 NCNT/NCORP 数据档案 COG 以外的研究人员可以获取 COG 完成的 2 期和 3 期研究的数据 通过 NCTN/NCORP 数据档案库 在本资助年中，数据将提交给 NCTN/NCORP 数据存档，用于总结多项研究结果的手稿。 Project EveryChild (PEC) 构建优化 Project:EveryChild 收集的数据将成为国家癌症中心的主要数据来源 研究所 (NCI) 儿童癌症数据倡议 (CCDI) 全球数据共享中心。 制定了家长/儿童研究构建计划，该计划允许形式变化的灵活性和 最大限度地减少规模较小的集中儿童学习移民的影响，大大减少 疾病特定请求更改所需的工作量和 url 资源。 RAVE 全球图书馆 COG 与 Westat 合作开发了编目和程序的流程和程序 按疾病领域对 COG 研究内部和跨研究的临床数据进行标准化，为 标准化数据采集将成为CCDI全球数据共享平台。 Medidata Rave 中全球 eCRF 库的基础，这将确保使用 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 实体瘤委员会希望增加肿瘤组织的生物样本库 复发时获得的资金将用于未来研究的临床注释。 提高复发时获得的肿瘤标本的数量和质量，并提高 已存储的生物样本的表征、稳定性和实用性。