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 丹娜—法伯癌症研究所 上一资助期的研究证实，实现 MRD 阴性状态可显着提高 优越的无进展生存和总生存结果。此外，IFM的研究表明，高剂量 化疗后进行自体干细胞移植 (HDT) 可提供显着的 PFS 益处。在帮助下 就该核心而言，DFCI 站点（测定研究）的结果最近刚刚揭盲，显示出显着的 HDT 的益处即使维持至进展。在此核心的帮助下，临床的新建议 在此更新申请中开发的研究旨在解决 MRD 状态如何为治疗方法提供信息。 该提议是进行一项随机 III 期研究，比较 HDT 与额外的诱导周期 MRD 阴性患者的治疗以及 MRD 阳性患者的单次 HDT 与串联 HDT 的比较。而且沿着 通过临床信息，使用患者生成了大量基因组和表观基因组数据 需要综合分析的样品。在上一个资助期间，核心支持了所有项目 规划、分析和整合。在本提案中，Core 将继续支持这项工作并将提供 1) 对临床和研究数据的格式、质量控制和注释程序的支持和指导 以及将研究数据传输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分析和综合分析以及3) 生物统计学支持 在所有项目的设计和分析方面。核心成员也将与所有项目成员密切合作 作为核心 1 和 2，涉及质量控制、样本跟踪和数据传输程序以及核心 3和4将进行下一代测序以鉴定基因组、表观基因组和转录组 在批量和单细胞水平上发生变化。不仅需要生物信息学和生物统计学的支持和分析 对于单个项目而言，但对于跨项目数据的综合分析至关重要，从而整体分析 该计划的成功。

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.