CORE--HUMAN STUDIES

CURE一直是胃肠道研究的前沿，它唯一能够将基础细胞进展转化为胃肠道疾病患者的人体研究。胃肠道疾病对生活质量和卫生保健服务需求的全国性影响凸显了其重要性和重要性。在此背景下，人类研究核心治疗：消化系统疾病研究核心中心(CURE：DDRCC)的使命是提供共享的资源、人员、服务、教育和咨询，以治疗：DDRCC研究人员、受训人员和他们的合作者，以研究选定的消化系统疾病患者。此核心的主要目标是促进协作、教育和 胃肠道临床、人体生理研究、翻译和健康结局研究在选定的消化系统疾病中的表现。虽然该中心的传统重点是研究消化性疾病及其病理生理学，但在上一次拨款申请中，重点已扩大到包括其他胃肠道疾病的研究，如胃食道反流病(GERD)、非溃疡性消化不良、肠易激综合征(IBS)、幽门螺杆菌感染、胃肠道出血和癌前疾病(慢性胃炎和巴雷特上皮)。在上一次供资期间，人们对以下方面的兴趣和重视大幅增加：1)恶性前驱疾病和进程；2)保健服务研究；3)在人文科学核心研究人员和CURE：DDRCC的基础科学研究人员之间启动跨学科研究项目， 强调中心研究的转化性；4)青年调查员或受训人员的职业发展和指导，以培养下一代以病人为导向的调查员。如下所示，这项工作非常成功，第五节(用户受益)和第七节(教育效益)。这个核心的具体目的是提供治疗：(1)高质量的临床研究单位(CRC)，用于低成本地进行胃肠道临床研究，总部设在CURE-VA，那里没有类似的临床研究单位用于研究特定的GI疾病；(2)利用装备齐全的内窥镜和门诊CRC单位进行GI临床、生理和翻译研究；(3)提供GI分泌测试、胃肠道动力和动态pH测试以及幽门螺杆菌评估(C13尿素呼气试验)的实验室服务；(4)临床研究技术教学和研究设计、数据管理、统计分析、常规咨询 结果；(5)选定的胃肠道疾病患者的组织和临床数据库(最大的数据库是Barrett上皮病、胃肠道出血、胶囊内窥镜检查-小肠疾病、胃肠道癌症、粘膜炎症-艾滋病和IBD以及功能性胃肠道疾病)；(6)关于进行健康结果研究的咨询，包括研究设计、成本评估、生活质量仪器、建模或成本效果研究；(7)胃肠道研究的专门设备(如研究小肠运动和形态障碍的胶囊内窥镜和研究胃肠道癌症的内窥镜超声)。 (8)研究胃肠道疾病和神经内脏疾病的胃肠动力实验室。这些服务和程序所需的仪器、附件和人员都很昂贵，因此在核心中的不同调查人员之间共享它们是具有成本效益的，并促进了合作。

CURE has always been on the forefront of gastrointestinal research, and it has been uniquely able to translate basic cellular advances into human studies in patients with gastrointestinal diseases. The importance and significance of GI disorders is highlighted by their national impact on quality of life and demand for health care services. In this context, the mission of the Human Studies Core of the CURE: Digestive Disease Research Core Center (CURE: DDRCC) is to provide shared resources, personnel, services, education, and consultation to CURE: DDRCC investigators, trainees, and their collaborators for the study of patients with selected digestive disorders. The primary goal of this Core is to facilitate collaboration, education about, and performance of GI clinical, human physiological studies, translational, and health outcomes studies in selected digestive disorders. Whereas the traditional focus of the center was investigation of peptic disorders and their pathophysiology, the focus was previously broadened in the last grant application to include the study of other gastrointestinal disorders such as gastroesophageal reflux disease (GERD), nonulcer dyspepsia, irritable bowel syndrome (IBS), Helicobacter pylori infection, gastrointestinal hemorrhage, and pre-cancerous conditions (chronic gastritis and Barrett's epithelium). During the last funding period, there has been a substantial increase in interest and emphasis on: 1) malignant foregut conditions and processes; 2) health services research; 3) initiation of interdisciplinary research projects among investigators of the Human Studies Core and basic science investigators of CURE: DDRCC, emphasizing the translational nature of research at the Center; 4) career development and mentoring of young investigators or trainees to develop the next generation of patient-oriented investigators. This has been very successful as shown below, Section V (Benefits to users) and VII, Educational Benefits. The specific purposes of this Core are to provide CURE: DDRCC members, trainees, and their collaborators with access to: (1) a quality clinical research unit (CRC) for performance of GI clinical research at a low cost, based at CURE-VA where no similar clinical research unit exists for the study of selected GI disorders; (2) utilization of fully equipped endoscopy and outpatient CRC units for GI clinical, physiologic, and translational research studies;, (3) laboratory services for GI secretory tests, GI motility and ambulatory pH testing, and H. pylori assessments (C 13 urea breath test);, (4) teaching of clinical research techniques and consultation about study design, data management, statistical analysis, and routine outcomes; (5) tissue and clinical data banks of patients with selected GI diseases (the largest data bases are for Barrett's epithelium, GI hemorrhage, capsule endoscopy-small bowel disorders, GI cancers, mucosal inflammatory diseases-AIDS and IBD, and functional GI disease); (6) consultation about conducting health outcomes research, including design of studies, cost assessments, quality of life instruments, and modeling or cost-effectiveness studies; (7) specialized equipment for GI studies (such as capsule endoscopy for studying small bowel motility and morphology disorders and endoscopic ultrasound for study of GI cancers and tissue through translational or collaborative research); (8) GI motility laboratory for the study of GERD and neurovisceral diseases. The instruments, accessories, and personnel required for these services and procedures are expensive, so that sharing them among various investigators in a Core is cost effective and promotes collaboration.