Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population (HELPER)

National Cancer Center (NCC)

Status and phase

Active, not recruiting

Phase 3

Conditions

Gastric Cancer

Helicobacter Pylori Infection

Treatments

Drug: 10-day bismuth-based quadruple therapy

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02112214

NCCCTS13716

1311240 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.

Full description

Despite the decreasing incidence observed in the US and West European countries, gastric cancer is still an important global public health problem, especially in East Asian countries, where the burden of the disease is substantial. In the Republic of Korea, gastric cancer remains the leading cause of cancer in men and the fourth most common cancer in women. There is sufficient epidemiological and experimental evidence supporting a causal link between bacterial infection with H. pylori and gastric cancer development. However, evidence from clinical trials on the efficacy of H. pylori eradication with antimicrobial therapy to reduce the risk of gastric cancer is still limited. In addition, the beneficial or deleterious health impact of mass eradication at the population level has not been defined. In Korea, the prevalence of H. pylori infection in adults is still relatively high (~60%, >16 years old), and despite important reductions in mortality attributed to the screening program, incidence of gastric cancer remains elevated.

The investigators propose to conduct a randomized controlled clinical trial in Korea to evaluate the efficacy of H. pylori eradication to prevent gastric cancer incidence in different population subgroups including age and baseline gastric pathology. This study will be conducted in the context of the National Cancer Screening Program and the Korean Central Cancer Registry.

The proposed study will be a collaborative investigation between the National Cancer Center, Korea and the International Agency for Research on Cancer of the World Health Organization.

Enrollment

5,224 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women aged 40-65 who are invited to participate in the National Cancer Screening Program and receive upper endoscopy
Willingness to sign an informed consent form
Good health, as determined by medical history and physical examination at enrollment

Exclusion criteria

Personal history of gastric cancer
Family history of gastric cancer in a first degree relative
Diagnosis and active treatment for other organ cancer except carcinoma in situ within 5 years
Current treatment for serious medical condition which could hinder participation (such as liver cirrhosis, renal failure, pulmonary dysfunction including COPD or asthma, or uncontrolled infection)
Inadequate cardiovascular function including (a) New York Heart Association class III or IV heart disease, (b) unstable angina or myocardial infarction history, (c) history of significant ventricular arrhythmia requiring medication with antiarrhythmics, and (d) history of cerebrovascular accident
Requirement for therapeutic anticoagulant therapy, aspirin
Gastric resections due to benign disease
H. pylori eradication therapy history
Mental incompetence to understand and sign informed consent
Alcoholism, drug abuse
Serious chronic diseases according to the evaluation of the study physician
Presence of a contraindication to the use of eradication treatment regimens
Inability to provide an informed consent
Pregnant or lactating women
Treatment required due to peptic ulcer, gastric cancer or esophageal cancer identified during the endoscopic examination