This proposal from the Johns Hopkins University is to continue as the Data Coordinating Center (DCC) of the Gastroparesis Clinical Research Consortium (GPCRC) to support the clinical centers as they complete three treatment trials (NORIG, GLUMIT-DG, APRON) and continue to gather biospecimens and data for patients with gastroparesis and related disorders in the Gastroparesis Registry. In addition, the DCC will support the Pathological Basis of Gastroparesis Study conducted by Dr. Farrugia at the Mayo Clinic in Rochester, MN for identification ofthe molecular factors involved in pathogenesis of gastroparesis. The goal ofthe GpCRC sponsored by the NIDDK since 2006 is to focus on the etiology, treatment strategies, and clinical course of gastroparesis. The DCC will continue to support the GpCRC and will be responsible for supporting any protocol development or modifications;providing sample size calculations, statistical advice, questionnaires, and data analysis;supporting development, implementation, and maintenance of a data base of clinical information and blood samples;developing or modifying any data monitoring plans;supporting manuscript preparation;and providing overall study coordination and quality assurance, including coordination ofthe activities and meetings of the Steering Committee (SC). The DCC will prepare or modify protocols for submission to the Data and Safety Monitoring Board (DSMB) and the SC for their approval prior to the implementation of any study protocols or protocol change. The DCC will be responsible for preparation of documents for submission to the Food and Drug Administration (FDA) in support of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications on behalf of the GPCRC. The DCC will prepare all reports including data reports for review by the DSMB at their meetings. The DCC will be responsible for acquiring and administering subcontracts as needed. The DCC will continue to work with the NIDDK Biosample, Genetic and Data Repositories and the clinical centers to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repositories.
Gastroparesis Consortium's research so far underscores the public health significance of gastroparesis including the need to develop effective methods for management of gastroparesis, the need to identify patients who are at risk of progression to more severe gastroparesis (including patients who are unable to maintain oral nutrition), and the need to identify the key cellular changes that lead to gastroparesis.
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|Parkman, Henry P; Yates, Katherine; Hasler, William L et al. (2013) Cholecystectomy and clinical presentations of gastroparesis. Dig Dis Sci 58:1062-73|
|Farrugia, G; Weinshilboum, R M (2013) Challenges in implementing genomic medicine: the Mayo Clinic Center for Individualized Medicine. Clin Pharmacol Ther 94:204-6|
|Gibbons, S J; Verhulst, P-J; Bharucha, A et al. (2013) Review article: carbon monoxide in gastrointestinal physiology and its potential in therapeutics. Aliment Pharmacol Ther 38:689-702|
|Hasler, W L; Wilson, L A; Parkman, H P et al. (2013) Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil 25:427-38, e300-1|
|Parkman, Henry P; Van Natta, Mark L; Abell, Thomas L et al. (2013) Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA 310:2640-9|
|Iorio, Raffaele; Lucchinetti, Claudia F; Lennon, Vanda A et al. (2013) Intractable nausea and vomiting from autoantibodies against a brain water channel. Clin Gastroenterol Hepatol 11:240-5|
|Grover, M; Bernard, C E; Pasricha, P J et al. (2012) Clinical-histological associations in gastroparesis: results from the Gastroparesis Clinical Research Consortium. Neurogastroenterol Motil 24:531-9, e249|
|Pasricha, Pankaj J; Colvin, Ryan; Yates, Katherine et al. (2011) Characteristics of patients with chronic unexplained nausea and vomiting and normal gastric emptying. Clin Gastroenterol Hepatol 9:567-76.e1-4|
|Parkman, Henry P; Yates, Katherine P; Hasler, William L et al. (2011) Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis. Gastroenterology 141:486-98, 498.e1-7|
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