NCT02112214

Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population

Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,224 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.

Detailed description

Despite the decreasing incidence observed in the US and West European countries, gastric cancer is still an important global public health problem, especially in East Asian countries, where the burden of the disease is substantial. In the Republic of Korea, gastric cancer remains the leading cause of cancer in men and the fourth most common cancer in women. There is sufficient epidemiological and experimental evidence supporting a causal link between bacterial infection with H. pylori and gastric cancer development. However, evidence from clinical trials on the efficacy of H. pylori eradication with antimicrobial therapy to reduce the risk of gastric cancer is still limited. In addition, the beneficial or deleterious health impact of mass eradication at the population level has not been defined. In Korea, the prevalence of H. pylori infection in adults is still relatively high (\~60%, \>16 years old), and despite important reductions in mortality attributed to the screening program, incidence of gastric cancer remains elevated. The investigators propose to conduct a randomized controlled clinical trial in Korea to evaluate the efficacy of H. pylori eradication to prevent gastric cancer incidence in different population subgroups including age and baseline gastric pathology. This study will be conducted in the context of the National Cancer Screening Program and the Korean Central Cancer Registry. The proposed study will be a collaborative investigation between the National Cancer Center, Korea and the International Agency for Research on Cancer of the World Health Organization.

Conditions

• Gastric Cancer
• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	10-day bismuth-based quadruple therapy	Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days
OTHER	Placebo	Placebo for bismuth-based quadruple therapy

Timeline

• Start date: 2014-06-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2014-04-11
• Last updated: 2024-12-27

Locations

11 sites across 1 country: South Korea