CORE--HUMAN STUDIES

核心——人类研究

• 批准号: 7415062
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 8.96万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7415062
• 关键词: Applications Grants; Barrett Epithelium; Basic Science; Breath Tests; Cancerous; Chronic Gastritis; Clinical; Clinical Data; Clinical Research; Collaborations; Condition; Consultations; Databases; Development; Digestive System Disorders; Disease; Education; Educational process of instructing; Endoscopy; Equipment; Functional disorder; Funding; Gastroesophageal reflux disease; Gastrointestinal Diseases; Gastrointestinal Hemorrhage; Goals; Health; Health Services; Health Services Research; Helicobacter Infections; Helicobacter pylori; Human; Human Resources; Inflammatory; Interdisciplinary Study; Investigation; Irritable Bowel Syndrome; Laboratories; Laboratory Study; Malignant - descriptor; Malignant Neoplasms; Mentors; Mission; Modeling; Morphology; Nature; Outcome; Outcome Study; Outcomes Research; Outpatients; Patients; Performance; Physiological; Primitive foregut structure; Procedures; Process; Purpose; Quality of life; Quality-of-Life Assessment; Research; Research Design; Research Personnel; Research Project Grants; Resource Sharing; Services; Small Intestines; Techniques; Testing; Tissues; Translating; Translational Research; Ultrasonography; Urea; base; capsule; career; cell motility; cost; cost effective; cost effectiveness; data management; gastrointestinal; human study; instrument; interest; member; next generation; nonulcer dyspepsia; patient oriented; research study

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 始终走在胃肠道研究的前沿，并且能够将基础细胞进展转化为胃肠道疾病患者的人体研究。胃肠道疾病对全国生活质量和医疗保健服务需求的影响凸显了其重要性和意义。在此背景下，CURE：消化疾病研究核心中心（CURE：DDRCC）人类研究核心的使命是为 CURE：DDRCC 的研究人员、学员及其合作者提供共享资源、人员、服务、教育和咨询，以研究患有选定消化疾病的患者。该核心的主要目标是促进协作、教育和 特定消化系统疾病的胃肠道临床、人类生理研究、转化和健康结果研究的表现。虽然该中心的传统重点是消化道疾病及其病理生理学的研究，但在上次拨款申请中，重点已扩大到包括其他胃肠道疾病的研究，例如胃食管反流病（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 癌前病变（慢性胃炎和巴雷特上皮）。在上一个资助期间，人们对以下方面的兴趣和重视程度大幅增加：1）恶性前肠状况和过程； 2）卫生服务研究； 3）在人类研究核心的研究人员和CURE的基础科学研究人员之间启动跨学科研究项目：DDRCC， 强调中心研究的转化性质； 4）年轻研究者或实习生的职业发展和指导，以培养下一代以患者为中心的研究者。这是非常成功的，如下所示，第五部分（对用户的好处）和第七部分，教育好处。该核心的具体目的是为 CURE：DDRCC 成员、学员及其合作者提供：(1) 一个高质量的临床研究单位 (CRC)，以低成本进行胃肠道临床研究，基于 CURE-VA，其中不存在用于研究选定胃肠道疾病的类似临床研究单位； (2) 利用设备齐全的内窥镜和门诊 CRC 单位进行胃肠道临床、生理和转化研究；(3) 胃肠道分泌测试、胃肠道运动和动态 pH 测试以及幽门螺杆菌评估（C 13 尿素呼气测试）的实验室服务；(4) 临床研究技术的教学以及有关研究设计、数据管理、统计分析和常规的咨询 结果； （5）特定胃肠道疾病患者的组织和临床数据库（最大的数据库是巴雷特上皮、胃肠道出血、胶囊内窥镜检查-小肠疾病、胃肠道癌症、粘膜炎症性疾病-艾滋病和IBD以及功能性胃肠道疾病）； (6) 关于开展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) 胃肠道研究的专用设备（例如用于研究小肠蠕动和形态异常的胶囊内窥镜以及用于研究胃肠道癌症的超声内窥镜） 和通过转化或合作研究组织）； (8) 胃肠动力实验室，用于研究GERD和神经内脏疾病。这些服务和程序所需的仪器、配件和人员都很昂贵，因此在核心中的各个研究人员之间共享它们既具有成本效益，又可以促进协作。