Core 5 - Biostatistics and Bioinformatics Core

核心 5 - 生物统计学和生物信息学核心

基本信息

批准号：
10555739
负责人：
Giovanni Luigi PARMIGIANI
金额：
$ 21.45万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-12-01 至 2028-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10555739
关键词：
Address Autologous Stem Cell Transplantation Basic Science Behavior Bioinformatics Biology Biometry Cells Clinical Clinical Research Clinical Trials Collaborations Color DNA Sequence Alteration Dana-Farber Cancer Institute Data Data Analyses Databases Dependence Development Diagnosis Disease Disease remission Evaluation Funding Genetic Transcription Genomics Goals Grant Heterogeneity High Dose Chemotherapy Immunotherapy Individual International Maintenance Maintenance Therapy Mediating Methods Multiple Myeloma Neoadjuvant Therapy Oncogenic Patients Phase III Clinical Trials Physical condensation Procedures Process Quality Control RNA RNA Binding Randomized Regulation Research Research Personnel Resistance Resolution Risk Role Sampling Site Specimen Stratification Therapeutic Tissue Banks Treatment Protocols Work Writing cancer genomics clinically relevant data exchange data warehouse design epigenomics high throughput analysis member next generation next generation sequencing novel strategies novel therapeutics outcome prediction phase 3 study pre-clinical programs response success survival outcome transcriptomics

项目摘要

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.

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此外，IFM 的研究表明，高剂量的治疗具有更好的无进展和总体生存结果。化疗后进行自体干细胞移植 (HDT) 可提供显着的 PFS 益处。就该核心而言，DFCI 站点（测定研究）的结果最近刚刚揭盲，显示出显着的在这个核心的帮助下，即使维持到进展，HDT 也能带来好处，这是临床的新建议。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。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在之前的资助期间，核心已经支持了所有需要综合分析的样本。在此提案中，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不仅需要批量和单细胞水平的变化。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。