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The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritis patients who have undergone endoscopic resection of early gastric cancer

ABSTRACT: Interventions: Drug : 1.At the time of EMR/ESD: Rapid Urease test/anti-helicobacter IgG Ab/ histology --> If two of them are (+), diagnosis of HP infection could be made. During endoscopy, designated biopsy for the evaluation of gastric atrophy should be performed (baseline data) 2.Patients are assigned to HP (+) or HP (-) group according to the HP status. (Each 120 patients) 3.HP (+) group should undergo eradication therapy after anti-ulcer medication (8weeks, LFDT 30mg + rebamipide SR 150mg bid), and diagnosis of successful eradication should be followed with urea breath test 4weeks later of last dose. 4.HP (-) group should undergo anti-ulcer medication (8weeks, LFDT 30mg + rebamipide SR 150mg bid). 5.In this time, patients are randomly allocated to rebamipide group (60 patients from each group) or placebo group (60 patients from each group). EGD with biopsy should be repeated to evaluate the regression of atrophy at the time of 12mo, 24mo, 36mo, 48mo, 60mo, respectively. Primary outcome(s): The primary outcome of this study is to evaluate the difference in the effect of between rebamipide and placebo on regression of gastric atrophy and intestinal metaplasia. Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : , Blinding Target : Subject, Investigator, Caregiver, Allocation : RCT

DISEASE(S): Diseases Of The Digestive System

PROVIDER: 26040 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Previously we reported that a recombinant vaccinia virus (VACV) carrying a light-emitting fusion gene enters, replicates in, and reveals the locations of tumors in mice. A new recombinant VACV, GLV-1h68, as a simultaneous diagnostic and therapeutic agent, was constructed by inserting three expression cassettes (encoding Renilla luciferase-green fluorescent protein (RUC-GFP) fusion, b-galactosidase, and b-glucuronidase) into the F14.5L, J2R (encoding thymidine kinase, TK), and A56R (encoding hemagglutinin, HA) loci of the viral genome, respectively. Intravenous (i.v.) injections of GLV-1h68 (1 Ã 107 pfu/mouse) into nude mice with established (500 mm3) subcutaneous (s.c.) GI-101A human breast tumors were used to evaluate its toxicity, tumor targeting specificity and oncolytic efficacy. GLV-1h68 demonstrated an enhanced tumor targeting specificity and much reduced toxicity compared to its parental LIVP strains. The tumors colonized by GLV-1h68 exhibited growth, inhibition, and regression phases followed by tumor eradication within 130 days in 95% of the mice tested. Tumor regression in live animals was monitored in real time based on decreasing light emission, hence demonstrating the concept of a combined oncolytic virus-mediated tumor diagnosis and therapy system. Transcriptional profiling of regressing tumors based on a mouse-specific platform revealed gene expression signatures consistent with immune defense activation, inclusive of interferon stimulated genes (STAT-1 and IRF-7), cytokines, chemokines and innate immune effector function. These findings suggest that immune activation may combine with viral oncolysis to induce tumor eradication in this model, providing a novel perspective for the design of oncolytic viral therapies for human cancers. Objective: To determine the gene expression changes induced by GLV-1h68 vaccinia virus injection in mouse carrying human breast cancer implant and leading to tumor eradication. Methods: Gene expression was analyzed using oligonucleotide microarrays. Responsiveness to vaccina virus injection was assessed by toxicity and survival study, gene expression anaysis and tumor volume change. Result: The tumors colonized by GLV-1h68 exhibited growth, inhibition, and regression phases followed by tumor eradication within 130 days in 95% of the mice tested. Tumor regression in live animals was monitored in real time based on decreasing light emission, hence demonstrating the concept of a combined oncolytic virus-mediated tumor diagnosis and therapy system. Transcriptional profiling of regressing tumors based on a mouse-specific platform revealed gene expression signatures consistent with immune defense activation, inclusive of interferon stimulated genes (STAT-1 and IRF-7), cytokines, chemokines and innate immune effector function. Conclusion: Our findings suggest that immune activation may combine with viral oncolysis to induce tumor eradication in this model, providing a novel perspective for the design of oncolytic viral therapies for human cancers. Experiment Overall Design: tumor tissues 3 and 6 weeks post virus injection

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The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritis patients who have undergone endoscopic resection of early gastric cancer

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