Core 5: Biostatistics and Bioinformatics

项目摘要（核心5） 上一个资助期的研究证实，实现MRD阴性（灵敏度为1个细胞/10 - 6） 状态提供显著优越的无进展和总体生存结局。在本提案中，我们将 解决MRD状态如何告知随机III期研究中的治疗方法的问题 比较MRD阴性患者的两种维持治疗方案。为了支持这项工作，生物信息学 和生物统计核心E将提供1）格式，质量控制和注释方面的支持和指导 临床和研究数据的程序以及将研究数据传输到数据库的过程 综合分析仓库，2）生物信息学支持的初级和综合分析的高， 生产量数据和3）生物统计学支持所有项目的设计和分析。核心成员将 与项目成员以及核心1和核心2在质量控制、样本跟踪方面密切合作 和数据传输程序，以及核心3和4，将执行基于基因和miRNA的微阵列 表达谱分析、SNP基因分型和下一代测序，用于鉴定基因组和 转录组学变化。生物信息学和生物统计学的支持和分析不仅需要个人 项目，但它是至关重要的综合分析，从数据的项目，从而整体成功的 节目

Project Summary (Core 5) Studies from the previous grant period confirmed that achieving MRD negative (sensitivity of 1 cell in 10-6) status provides significantly superior progression free and overall survival outcome. In this proposal, we will address the question of how MRD status will inform the therapeutic approach in a randomized phase III study comparing two maintenance schedules for MRD negative patients. To support this effort, the Bioinformatics and Biostatistics Core E will provide 1) support and direction on the formatting, quality control and annotation procedures of clinical and research data as well as the process of transferring the research data a data warehouse for integrative analysis, 2) bioinformatics support for primary and integrative analysis of the high- throughput data and 3) biostatistics support in terms of design and analysis for all projects. Core members will work closely with project members as well as Cores 1 and 2 with regard to quality control, specimen tracking and data transfer procedures as well as Cores 3 and 4 which will perform microarray based gene and miRNA expression profiling, and SNP genotyping and next generation sequencing for identifying genomic and transcriptomic changes. Bioinformatics and biostatistics support and analysis is not only required for individual projects, but it is crucial for the integrative analysis from data across the projects and thus overall success of the program.