Core 5: Biostatistics and Bioinformatics

项目摘要(核心5) 上一次赠款期间的研究证实，达到MRD阴性(1个细胞的灵敏度为10-6) 状态提供了显著优越的无进展和总体生存结果。在这项提案中，我们将 在一项随机的III期研究中，解决MRD状态将如何影响治疗方法的问题 MRD阴性患者两种维护方案的比较。为了支持这一努力，生物信息学 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转换为数据的过程 用于综合分析的仓库；2)生物信息学支持，用于高、低成本的初级和综合分析 吞吐量数据和3)在所有项目的设计和分析方面的生物统计支持。核心成员将 与项目成员以及核心1和2在质量控制、样品跟踪方面密切合作 以及数据传输程序以及将执行基于微阵列的基因和miRNA的核心3和4 表达谱分析，SNP基因分型和下一代测序，以识别基因组和 转录改变。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，但它对跨项目的数据的综合分析至关重要，从而使 这个项目。

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.