Gastric Cancer, Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori treatment, Gastric cancer, Screening
Brief summary
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.
Detailed 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.
Interventions
DRUG10-day bismuth-based quadruple therapy
Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days
OTHERPlacebo
Placebo for bismuth-based quadruple therapy
Sponsors
International Agency for Research on Cancer
Chonnam National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Pusan National University Hospital
Kyungpook National University Hospital
Uijeongbu St. Mary's Hospital/The Catholic University
Kangdong Sacred Heart Hospital
Incheon St.Mary's Hospital/The Catholic University
SMG-SNU Boramae Medical Center
Chuncheon Sacred Heart Hospital
Kosin University Gospel Hospital
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of gastric cancer between the intervention and placebo groups | Up to 10 years After H. pylori eradication | Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gastric dysplasia | Up to 10 years After H. pylori eradication | Diagnosis of histologically confirmed gastric dysplasia |
| Occurrence of adverse events caused by antibiotic treatment | During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion | Solicited/unsolicited adverse events |
| Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment | Up to 10 years After H. pylori eradication | Assessed through record linkage or direct assessment during screening visits |
| All-cause mortality | Up to 10 years After H. pylori eradication | Korean National Health Insurance records or other reports |
| Modification of atrophy score | Up to 10 years After H. pylori eradication | Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment |
| Mortality from gastric cancer | Up to 10 years after eradication | Cancer registry or other reports |
Countries
South Korea
Outcome results
None listed