Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

National Cancer Center (NCC)

Status and phase: Active, not recruiting; Phase 3

Conditions: Family Members; Gastric Cancer; Helicobacter Pylori Infection

Treatments: Drug: Placebo; Drug: LAC triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01678027

NCCCTS04-103

Details and patient eligibility

About

This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.

Full 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.

Enrollment: 1,838 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,838 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for LAC triple therapy

Treatment:

Drug: Placebo

LAC triple therapy

Active Comparator group

Description:

PPI (Lansoprazole), Clarithromycin, Amoxicilline

Treatment:

Drug: LAC triple therapy