Core 5 - Biostatistics and Bioinformatics Core

项目摘要-核心5 -生物统计学和生物信息学核心Dana-Farber癌症研究所 上一个资助期的研究证实，达到MRD阴性状态， 上级无进展和总生存结局。此外，IFM的研究表明，高剂量 化疗后自体干细胞移植（HDT）提供了显着的PFS的好处。借助 在该核心中，DFCI研究中心（测定研究）的结果最近刚刚揭盲，显示出显著的 HDT的益处，即使维持至进展。在这个核心的帮助下，临床的新建议 在本次更新申请中开发了一项研究，以解决MRD状态如何为治疗方法提供信息。 该建议是进行一项随机III期研究，比较HDT与额外的诱导周期 MRD阴性患者的单次与串联HDT以及MRD阳性患者的单次与串联HDT。而且沿着 对于临床信息，已经使用患者产生了大量的基因组和表观基因组数据， 需要综合分析的样品。在上一个供资期间，核心方案支助了所有项目， 规划、分析和整合。在本提案中，核心将继续支持这一努力，并将提供1） 支持和指导临床和研究数据的格式、质量控制和注释程序 以及将研究数据转移到数据仓库进行综合分析的过程; 2） 生物信息学支持高通量数据的初步和综合分析，以及3）生物统计学支持 在所有项目的设计和分析方面。核心成员将与所有项目成员密切合作，以及 在质量控制、样本跟踪和数据传输程序方面， 3和4，将进行下一代测序，以确定基因组，表观基因组和转录组 在整体和单个细胞水平上的变化。不仅需要生物信息学和生物统计学的支持和分析， 对于单个项目，但对于跨项目数据的综合分析至关重要， 方案的成功。

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.