Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Phase 3

Active, not recruiting

• Conditions: Helicobacter Pylori Infection; Gastric Cancer; Family Members
• Interventions: Drug: LAC triple therapy; Drug: Placebo

• Registration Number: NCT01678027
• Lead Sponsor: National Cancer Center, Korea

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Primary Completion: 2018-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1838

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAC triple therapy	LAC triple therapy	PPI (Lansoprazole), Clarithromycin, Amoxicilline
Placebo	Placebo	Placebo for LAC triple therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Gastric dysplasia incidence	6 year after last participant enrollment	Incidence of gastric dysplasia according to the H. pylori treatment
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
All-cause mortality	6 year after last participant enrollment	All-cause mortality between H. pylori treatment group and placebo group

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of