Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for LAC triple therapy |
|
| LAC triple therapy | Active Comparator | PPI (Lansoprazole), Clarithromycin, Amoxicilline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric cancer incidence | 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. | 6 years after last participant enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric dysplasia incidence | Incidence of gastric dysplasia according to the H. pylori treatment | 6 year after last participant enrollment |
| Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Il Ju Choi, M.D., Ph.D. | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31995688 | Derived | Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, Joo J. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LAC triple therapy | Drug | Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week. |
|
|
Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
| 6 year after last participant enrollment |
| Gastric cancer incidence according to H. pylori status | Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group | 6 year after last participant enrollment |
| All-cause mortality | All-cause mortality between H. pylori treatment group and placebo group | 6 year after last participant enrollment |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |