ZIA CP010182-00446 (ZIA) | |||
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Title | Gastric cancer: Randomized multi-intervention trial to inhibit precancerous gastr | ||
Institution | NCI, Bethesda, Ma | ||
Principal Investigator | Gail, Mitchell | NCI Program Director | N/A |
Cancer Activity | N/A | Division | DCEG |
Funded Amount | $30,126 | Project Dates | 02/01/1995 - N/A |
Fiscal Year | 2011 | Project Type | Intramural |
Research Topics w/ Percent Relevance | Cancer Types w/ Percent Relevance | ||
Alcoholism Research (10.0%) Biochemical Epidemiology (45.0%) Cancer (100.0%) Chemoprevention (100.0%) Digestive Diseases (100.0%) |
Stomach (100.0%) | ||
Research Type | |||
Exogenous Factors in the Origin and Cause of Cancer Interventions to Prevent Cancer: Personal Behaviors That Affect Cancer Risk |
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Abstract | |||
An 8-year collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Heliobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis was conducted. The primary endopoint was not be cancer, but rather the precancerous lesions severe chronic strophic gastritis, intestinal metaplasia, and dysplasia. The study was designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial also provided an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial were approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. These individuals were be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2^3 factorial design. The interventions were: 1) initial treatment of H. pylori infection with omeprazole & amoxicllin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, & selenium; & 3) daily supplementation with garlic extracts. Gastroscopic exams with biopsies at 7 standard gastric sites were conducted during March to May, 2003 to detect early cancers and to evaluate gastric mucosal status. The subjects were categorized according to the most advanced lesions detected in all biopsies and assigned a severity scores. The three major endpoints for analysis were: 1) prevalence of dysplasia or cancer 2) prevalence of severe chronic atrophic gastritis, intestinal metaplasia, dysplasioa, or cancer; & 3) average severity score. |