CORE--HUMAN STUDIES

核心——人类研究

• 批准号: 6825453
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 9.22万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6825453
• 关键词: biomedical facility; clinical chemistry; clinical research; digestive disorder; endoscopy; patient /disease registry

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.

CURE一直是胃肠道研究的最前沿，并且它具有独特的能力，可以将基本细胞进展转化为胃肠道疾病患者的人类研究。胃肠道疾病的重要性和意义是由于其国家对生活质量和对医疗服务的需求的影响而强调了。在这种情况下，治愈的人类研究核心的使命：消化疾病研究核心中心（CURE：DDRCC）是为治疗提供共同的资源，人员，服务，教育和咨询：DDRCC调查人员，受训者及其合作者，以研究精选消化系统疾病的患者。该核心的主要目的是促进合作，教育以及 GI临床，人类生理研究，转化和健康结果研究的表现。 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癌前病（慢性胃炎和巴雷特上皮）。在最后一个资金期间，兴趣和强调兴趣大幅增加：1）恶性前述条件和过程； 2）卫生服务研究； 3）人类研究研究者核心研究人员和基础科学研究者的跨学科研究项目的启动：DDRCC， 强调中心研究的翻译性质； 4）年轻的研究人员或学员的职业发展和指导，以发展下一代以患者为导向的研究人员。如下所示，这非常成功，第五节（对用户的好处）和VII，教育福利。该核心的具体目的是提供治疗：DDRCC成员，受训者及其合作者可以访问：（1）在Cure-VA上以低成本进行GI临床研究的优质临床研究部门（CRC），在CURE-VA中，没有类似的临床研究单位可用于研究选定的GIOSORDERS的研究； （2）用于GI临床，生理和翻译研究的设备齐全的内窥镜检查和门诊CRC单元；（3）用于GI分泌测试，GI运动和卧床pH测试的实验室服务，以及H.幽门螺杆菌评估（C 13尿素呼吸测试）（C 13尿素呼吸测试）； 结果； （5）患有胃肠道疾病的患者的组织和临床数据库（最大的数据库是针对Barrett的上皮，胃肠道出血，胶囊内窥镜 - 小肠疾病，GI癌，粘膜癌症，粘膜炎性疾病疾病AID和IBD和功能性GI病）； （6）有关进行健康结果研究的咨询，包括研究设计，成本评估，生活质量工具以及建模或成本效益研究； （7）用于GI研究的专用设备（例如用于研究小肠运动性和形态疾病的胶囊内窥镜检查以及用于研究GI癌的内窥镜超声 和组织通过转化或协作研究）； （8）研究GERD和神经疾病疾病的GI运动实验室。这些服务和程序所需的工具，配件和人员很昂贵，因此在核心的各个研究人员中共享它们具有成本效益并促进协作。