Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study

Conditions
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Gastric Cancer, Helicobacter Pylori Infection, Family Members

Intervention / Treatment
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* Drug: Placebo
* Drug: LAC triple therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo for LAC triple therapy | Drug: Placebo<br>* Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.<br>|
| Active Comparator: LAC triple therapy<br>PPI (Lansoprazole), Clarithromycin, Amoxicilline | Drug: LAC triple therapy<br>* Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.<br>* Other names: PPI-Clarithromycin containing triple therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach neoplasm, Helicobacter pylori