Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.
Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Drug: LAC triple therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study|
- Gastric cancer incidence [ Time Frame: 6 years after last participant enrollment ] [ Designated as safety issue: No ]
The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status.
Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
- Gastric cancer incidence [ Time Frame: 6 year after last participant enrollment ] [ Designated as safety issue: No ]Incidence of gastric cancer according to the final H. pylori infection status
- Gastric cancer incidence [ Time Frame: 6 year after last participant enrollment ] [ Designated as safety issue: No ]Gastric cancer incidence according to the initial gastric mucosal atrophy grade and intestinal metaplasia grade
|Study Start Date:||November 2004|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
|Active Comparator: LAC triple therapy||
Drug: LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
|Korea, Republic of|
|National Cancer Center, Korea|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Principal Investigator:||Il Ju Choi, M.D., Ph.D.||National Cancer Center, Korea|