Core 5 - Biostatistics and Bioinformatics Core

项目摘要-核心5-生物统计和生物信息学核心Dana-Farber癌症研究所 上一次赠款期间的研究证实，达到MRD阴性状态将提供显著的 优越的无进展和总体生存结果。此外，IFM的研究表明，高剂量 化疗后的自体干细胞移植(HDT)提供了显著的PFS益处。在我的帮助下 在这个核心中，DFCI站点的结果(确定研究)最近才非盲目地显示出显著的 HDT的好处，即使是维护，直到进展。在这个核心的帮助下，临床的新建议 在这一更新申请中开展了一项研究，以解决MRD状态如何影响治疗方法。 该建议是进行一项随机的第三阶段研究，比较HDT和额外的诱导周期 对MRD阴性患者进行治疗，对MRD阳性患者进行单次与串联HDT治疗。此外，沿着 通过临床信息，利用患者产生了大量的基因组和表观基因组数据 需要综合分析的样本。在之前的供资期间，核心基金支持了所有项目， 规划、分析和整合。在本建议书中，Core将继续支持这一努力，并将提供1) 对临床和研究数据的格式化、质量控制和注释程序提供支持和指导 以及将研究数据转移到数据仓库进行综合分析的过程，2) 为高通量数据的初级和综合分析提供生物信息学支持和3)生物统计支持 在所有项目的设计和分析方面。核心成员也将与所有项目成员密切合作 作为岩芯1和2在质量控制、样品跟踪和数据传输程序以及岩芯方面 3和4将执行下一代测序以识别基因组、表观基因组和转录组 在整体和单细胞水平上的变化。生物信息学和生物统计学的支持和分析不仅需要 对于单个项目，但它对于跨项目的数据的综合分析以及整体分析是至关重要的 节目的成功。

Project Summary – Core 5 – Biostatistics and Bioinformatics Core Dana-Farber Cancer Institute Studies from the previous grant period confirmed that achieving MRD negative status provides significantly superior progression free and overall survival outcome. Moreover, the studies by IFM have shown that high dose chemotherapy followed by autologous stem cell transplant (HDT) provide significant PFS benefit. With the help of this Core, the results of the DFCI sites (determination study) were just recently unblinded showing a significant benefit of HDT even with maintenance till progression. With the help of this Core, the new proposal for clinical study was developed in this renewal application to address how MRD status can inform the therapeutic approach. The proposal is to perform a randomized phase III study comparing HDT versus additional cycles of induction therapy for MRD negative patients and single versus tandem HDT for MRD positive patients. Moreover along with clinical information a large amount of genomic and epigenomic data has been generated using the patients samples that requires integrated analysis. In the prior funding period the Core has supported all the projects with planning, analysis and integration. In this proposal Core will continue to support this effort and 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 all 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 next generation sequencing for identifying genomic, epigenomic and transcriptomic changes at bulk and single cell level. 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.