Family Members, Gastric Cancer, Helicobacter Pylori Infection
Conditions
Keywords
Stomach neoplasm, Helicobacter pylori
Brief summary
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.
Detailed description
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.
Interventions
DRUGPlacebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
DRUGLAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy * Informed consent should be signed
Exclusion criteria
* Gastric cancer history * Other malignancy within the past 5 years * Hereditary cancer family member (HNPCC, FAP) * Peptic ulcer history * Peptic ulcer, esophageal cancer, gastric cancer case found at EGD * H. pylori eradication treatment history * Previous serious side effect to antibiotics * Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases * Pregnant or nursing women * Psychiatric disorder that would preclude compliance, alcoholics * Refuse informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric cancer incidence | 6 years after last participant enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups | 6 year after last participant enrollment | Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group |
| Gastric dysplasia incidence | 6 year after last participant enrollment | Incidence of gastric dysplasia according to the H. pylori treatment |
| Gastric cancer incidence according to H. pylori status | 6 year after last participant enrollment | Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group |
| All-cause mortality | 6 year after last participant enrollment | All-cause mortality between H. pylori treatment group and placebo group |
Countries
South Korea
Outcome results
None listed