Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 1,838
- Locations
- 1
- Primary Endpoint
- Gastric cancer incidence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
LAC triple therapy
PPI (Lansoprazole), Clarithromycin, Amoxicilline
Intervention: LAC triple therapy (Drug)
Placebo
Placebo for LAC triple therapy
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Gastric cancer incidence
Time Frame: 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 Outcomes
- Gastric dysplasia incidence(6 year after last participant enrollment)
- Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups(6 year after last participant enrollment)
- Gastric cancer incidence according to H. pylori status(6 year after last participant enrollment)
- All-cause mortality(6 year after last participant enrollment)
Investigators
Il Ju Choi
M.D., Ph.D
National Cancer Center, Korea