Core C: Biostatistics Core

项目概要/核心C摘要 慢性移植物抗宿主病（cGVHD）是晚期发病、生活质量受损和 异基因造血细胞移植（HCT）后的死亡率。尽管如此，进展甚微 在cGVHD的预防和治疗中，部分原因是对cGVHD的病理生理学知之甚少。的 cGVHD的病理生理学不同于急性GVHD，并且涉及B细胞。的主要目的 因此，本计划项目申请中的研究项目是研究B细胞在 cGVHD的病理生理学具体来说，项目1致力于专门针对B细胞的临床试验 用于预防和治疗cGVHD的隔室。项目2将研究靶向 使用已建立的稳健小鼠模型的生发中心、浆细胞和胶原蛋白的免疫识别 cGVHD。项目3将使用来自临床试验的样本检测B细胞对H-Y抗原的反应， B细胞耗竭和血清学同种抗体耗竭与临床反应，执行新的同种抗原 发现研究，并研究同种异体反应性B细胞的生物学，以确定可以 cGVHD的治疗靶点。 生物统计核心（核心C）的主要目标是为所有人提供统计合作。 参与该项目的研究人员。这包括与项目调查人员合作， 设计项目1的临床试验和项目2和3的实验室实验，分析临床和 实验室数据，并建立项目1-3中临床结局与实验室结果的相关性，以及 参与所有项目的手稿撰写。核心C还将为翻译提供研究基础设施。 所有项目和计算资源的研究。该等服务将在林博士的指导下执行。 金，核心C领导人，并将在4个具体目标进行： 1)为转化临床研究提供生物统计学合作。 2)为转化动物研究提供生物统计学合作。 3)为转化实验室研究提供生物统计学合作。 3)为转化研究和计算资源提供研究基础设施 用于数据处理、统计分析、标准化报告和质量控制。

Project Summary/Abstract Core C Chronic graft-versus-host disease (cGVHD) is the leading cause of late morbidity, impaired quality of life, and mortality after allogeneic hematopoietic cell transplantation (HCT). Despite this, little progress has been made in cGVHD prevention and therapy in part because the pathophysiology of cGVHD is poorly understood. The pathophysiology of cGVHD is distinct from acute GVHD, and B cells are implicated. The primary objective of research projects in this Program Project application is thus to study the role of the B cell in the pathophysiology of cGVHD. Specifically, Project 1 is dedicated to clinical trials that specifically target the B cell compartment for the prevention and treatment of cGVHD. Project 2 will examine novel drugs that target germinal centers, plasma cells, and immune recognition of collagen using an established robust mouse model of cGVHD. Project 3 will examine B cell responses to H-Y antigens using samples from clinical trials, correlate B cell depletion and serologic alloantibody depletion with clinical responses, perform novel alloantigen discovery studies, and study the biology of alloreactive B cells to determine signaling pathways that can be therapeutically targeted in cGVHD. The primary objective of the Biostatistics Core (Core C) is to provide statistical collaboration for all investigators involved in this Program Project. This includes collaboration with project investigators in the design of clinical trials in Project 1 and laboratory experiments in Projects 2 and 3, analysis of clinical and laboratory data and to establish correlations of clinical outcomes with laboratory results in Projects 1-3, and participate in manuscript writing in all Projects. Core C will also provide research infrastructure for translational research in all projects and computing resources. These services will be executed under the direction of Dr. Kim, Core C Leader, and will be carried out in 4 Specific Aims: 1) To provide biostatistical collaboration for translational clinical research studies. 2) To provide biostatistical collaboration for translational animal research studies. 3) To provide biostatistical collaboration for translational laboratory research studies. 3) To provide research infrastructure for translational research and computing resources for data processing, and statistical analysis, standardized reporting, and quality control.