Data & Analysis Core

数据

• 批准号: 10657451
• 负责人: Christopher I. Amos
• 金额: $ 30.42万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10657451
• 关键词: Address; Biochemical Markers; Blinded; Chemoprevention; Chemopreventive Agent; Cirrhosis; Cities; Clinical; Clinical Research; Comprehensive Cancer Center; Data; Data Analyses; Data Collection; Data Linkages; Data Set; Development; Diabetes Mellitus; Early Diagnosis; Effectiveness; Electronics; Enrollment; Ensure; Epidemiology; Equipment and supply inventories; Etiology; Functional disorder; Funding; Future; Genetic Markers; Goals; Human Resources; Individual; Informatics; Information Technology; Machine Learning; Malignant neoplasm of liver; Manuals; Mathematics; Medicine; Metabolic; Metabolic dysfunction; Metabolic syndrome; Metformin; Mission; Monitor; Obesity; Participant; Patients; Persons; Prevention; Prevention strategy; Primary carcinoma of the liver cells; Process; Prospective cohort; Protocols documentation; Research Design; Research Personnel; Resource Sharing; Resources; Retrieval; Retrospective cohort; Risk Factors; Risk Reduction; Sampling; Science; Services; Site; Specimen; Statistical Data Interpretation; Statistical Methods; Statistical Models; Support System; System; Technology; Testing; Texas; Thiazolidinediones; Translational Research; United States Department of Veterans Affairs; Update; Vertebral column; Work; biomarker development; biomarker discovery; biomarker validation; central database; cohort; college; comparative; cost; dashboard; data harmonization; data management; design; epidemiologic data; experience; fatty liver disease; follow-up; member; metabolic-associated fatty liver disease; models and simulation; mortality; multidimensional data; novel marker; operation; participant enrollment; phenotypic biomarker; professor; programs; quality assurance; recruit; research study; risk stratification; skills; statistics; stem; success; synergism; timeline; tool; validation studies; web platform

ABSTRACT— Data and Analysis Core The Program Project (PP) overarching goal is to reduce the burden of hepatocellular carcinoma (HCC)-related mortality. We will achieve this goal by enhancing the understanding of contemporary risk factors (e.g., phenotypic, biochemical, and genetic markers of metabolic dysfunction) and preventive strategies (e.g., chemoprevention, surveillance) for rapidly increasing HCC related to metabolic (dysfunction) associated fatty liver disease (MAFLD). The PP includes three Projects; two shared resource cores, the Data and Analysis Core (DAC) and the Biospecimen and Biomarker Development Core (BBDC); and the Administrative Core, all with the shared mission of stemming the rising tide of MAFLD-HCC. Central to this PP is leveraging and expanding our multicity, ongoing prospective cohort of persons with MAFLD- related cirrhosis, as well as a retrospective cohort identified in the national Department of Veterans Affairs (VA) datasets. The aims of the three projects require rigorous implementation of well-designed protocols for coordination and implementation of patient enrollment and biospecimen and data collection. Further, they need optimal, complete follow-up of patients with cirrhosis to determine if the participants developed HCC. The BBDC requires support programs and systems to track samples between enrollment sites to identify and select samples for testing related to specific projects. All three PP studies also require rigorous advanced methods for statistical analyses and information technology. All these needs will be addressed by the DAC. The goal of the DAC is to provide critical expertise and support in data management, coordination, statistics and information technology for all projects in the PP. The Specific Aims of DAC are to provide the PP projects and BDCC with (1) Management and coordination, including implementing and maintaining a Manual of Operation (MOO) of the multicity, multisite prospective cohort; (2) Programming and systems support to maintain central databases for PP Projects, track samples, design programs to monitor study data, and develop electronic dashboards to ensure regulatory compliance and timely progress of PP Projects and Cores; (3) Statistical expertise for programming, ongoing quality assurance, study design guidance, and analysis and interpretation of data; and (4) Informatics technology to harmonize data collection efforts among PP investigators and collaborators and to develop apps for users that interface with simulation models. DAC members have extensive experience and expertise in the design and statistical analyses of variety of study as well as continuity of skills, protocols and personnel related to the THCCC cohort. DAC will ensure the all Projects and Cores achieve the overarching goal of reducing HCC related mortality.

摘要-数据和分析核心 该计划项目（PP）的总体目标是减少肝细胞癌（HCC）相关的负担。 mortality.我们将通过加强对当代风险因素的理解来实现这一目标（例如， 代谢功能障碍的表型、生物化学和遗传标记）和预防策略（例如， 与代谢（功能障碍）相关的脂肪肝相关的快速增加的HCC 肝病（MAFLD）。PP包括三个项目;两个共享资源核心，数据和分析 核心（DAC）和生物标本和生物标志物开发核心（BBDC）;以及行政核心，所有 共同的使命是阻止MAFLD-HCC的上升趋势。 该PP的核心是利用和扩大我们的多城市，持续的MAFLD患者前瞻性队列- 相关肝硬化，以及在国家退伍军人事务部（VA）确定的回顾性队列 数据集。这三个项目的目标要求严格执行精心设计的协议， 协调和实施患者入组、生物样本和数据收集。此外，他们需要 对肝硬化患者进行最佳、完整的随访，以确定参与者是否发展为HCC。BBDC 需要支持程序和系统来跟踪入组研究中心之间的样本，以识别和选择 用于测试与特定项目相关的样品。所有三项PP研究也都需要严格的先进方法 用于统计分析和信息技术。所有这些需求都将由发援会解决。 发展援助委员会的目标是在数据管理、协调、统计、 和信息技术为所有项目的PP。DAC的具体目标是提供PP项目 （1）管理和协调，包括执行和维持一份《发展筹资问题手册》， 多城市、多地点前瞻性队列的运作;（2）方案编制和系统支助， 维护PP项目的中央数据库，跟踪样本，设计监控研究数据的程序，并开发 电子仪表板，以确保PP项目和核心的合规性和及时进展;（3） 编程、持续质量保证、研究设计指导和分析的统计专业知识， 数据解释;以及（4）信息技术，以协调参与方之间的数据收集工作 研究人员和合作者，并为用户开发与模拟模型接口的应用程序。 发展援助委员会成员在设计和统计分析各种 研究以及与THCCC队列相关的技能、协议和人员的连续性。DAC将确保 所有项目和核心都实现了降低肝癌相关死亡率的总体目标。