Biostatistics and Bioinformatics Core

生物统计学和生物信息学核心

基本信息

批准号：
10246890
负责人：
JAMES E HERNDON
金额：
$ 20.03万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10246890
关键词：
Algorithms Antigens Bayesian Modeling Bioinformatics Biometry Brain Brain Neoplasms Clinical Research Clinical Trials Collaborations Correlative Study Cytomegalovirus Data Data Analyses Dendritic Cell Vaccine Diagnosis Diphtheria Toxoid Ensure Flow Cytometry Genetic Models Glioblastoma Glioma Immunologic Monitoring Immunotherapeutic agent Immunotherapy Infusion procedures Investigational Therapies Leadership Lomustine Malignant neoplasm of brain Manuscripts Methodology Methods Modeling Monitor Monoclonal Antibodies Newly Diagnosed Oncolytic poliovirus Patients Preparation Prognosis Program Research Project Grants Randomized Recurrence Reporting Research Research Design Research Personnel Research Project Grants Resources Safety Sample Size Science Stains T cell receptor repertoire sequencing Tetanus clinical imaging data integrity design improved innovation member monocyte multiplex assay novel preconditioning programs

项目摘要

PROJECT SUMMARY – Core 1 This Biostatistics and Bioinformatics Core (Core 1) will serve as an essential central resource to support the quantitative needs of research projects proposed by investigators involved in this Program Project Grant (PPG). Specifically, this Core will provide biostatistics and bioinformatics leadership and expertise in collaboration with the Clinical Trials and Imaging Core (Core 2) and Correlative Sciences and Immune Monitoring Core (Core 3) to all three proposed Projects. These projects investigate the safety, efficacy and mechanisms of novel immunotherapeutic approaches to the treatment of patients with glioblastoma, a diagnosis with extremely poor prognosis. Project 1 investigates the use of Cytomegalovirus (CMV) pp65 loaded dendritic cell (DC) vaccines with Td pre-conditioning and CD27 monoclonal antibody in patients newly diagnosed with glioblastoma (GBM), Project 2 assesses infusions of monocytes transfected with GBM Ag CMV pp65-LAMP in patients newly diagnosed with GBM, and Project 3 studies oncolytic poliovirus (PVSRIPO) immunotherapy with subsequent lomustine in patients with recurrent WHO grade 4 glioma. Innovative, state- of-the art methodology will be used by this Core in the statistical design and analysis of proposed clinical trials and correlative studies.

项目摘要 – 核心 1 该生物统计学和生物信息学核心（核心 1）将作为支持的重要中央资源参与本计划项目资助的研究人员提出的研究项目的定量需求具体来说，该核心将提供生物统计学和生物信息学方面的领导力和专业知识。与临床试验和影像核心（核心 2）以及相关科学和免疫合作监测核心（核心 3）对所有三个拟议项目进行安全性、有效性和安全性调查。治疗胶质母细胞瘤患者的新型免疫治疗方法的机制项目 1 研究了巨细胞病毒 (CMV) pp65 的使用。新为患者提供 Td 预处理和 CD27 单克隆抗体的负载树突状细胞 (DC) 疫苗诊断患有胶质母细胞瘤 (GBM)，项目 2 评估转染 GBM Ag CMV 的单核细胞输注新诊断 GBM 患者中的 pp65-LAMP，项目 3 研究溶瘤脊髓灰质炎病毒 (PVSRIPO) 随后使用洛莫司汀对复发性 WHO 4 级神经胶质瘤患者进行免疫治疗，创新性的、国家级的。该核心将使用最先进的方法对拟议的临床试验进行统计设计和分析及相关研究。