Helicobacter Pylori Eradication to Prevent Gastric Cancer
Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.
Drug: OAC triple therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial|
- Gastric cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: No ]The incidence of gastric cancer in the two groups
- Histopathological changes [ Time Frame: 10 years ] [ Designated as safety issue: No ]The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||May 2020|
|Estimated Primary Completion Date:||May 2020 (Final data collection date for primary outcome measure)|
|Experimental: OAC triple therapy||
Drug: OAC triple therapy
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
|Placebo Comparator: Placebo||
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133951
|Zhao-Lai Hua M.D.|
|Yangzhong City, Jiangsu, China, 212200|
|Study Chair:||Jie J Wang, M.D.||Shanghai Changzheng Hospital affiliated to Second Military Medical University|
|Principal Investigator:||Xi Wang, M.D.||Shanghai Changzheng Hospital affiliated to Second Military Medical University|