CORE--HUMAN STUDIES

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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.