Clinical trial NCT02112214: Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population
Official title: Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Helicobacter Pylori Infection
Keywords: Helicobacter pylori treatment
Gastric cancer
Screening
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: International Agency for Research on Cancer
name: Chonnam National University Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Pusan National University Hospital
name: Kyungpook National University Hospital
name: Uijeongbu St. Mary's Hospital/The Catholic University
name: Kangdong Sacred Heart Hospital
name: Incheon St.Mary's Hospital/The Catholic University
name: SMG-SNU Boramae Medical Center
name: Chuncheon Sacred Heart Hospital
name: Kosin University Gospel Hospital
First posted: 2014-04-11
Enrollment: 5224
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of gastric cancer between the intervention and placebo groups
timeFrame: Up to 10 years After H. pylori eradication
Secondary outcomes:
measure: Incidence of gastric dysplasia
timeFrame: Up to 10 years After H. pylori eradication
measure: Occurrence of adverse events caused by antibiotic treatment
timeFrame: During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion
measure: Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment
timeFrame: Up to 10 years After H. pylori eradication
measure: Mortality from gastric cancer
timeFrame: Up to 10 years after eradication
measure: All-cause mortality
timeFrame: Up to 10 years After H. pylori eradication
measure: Modification of atrophy score
timeFrame: Up to 10 years After H. pylori eradication
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital/The Catholic University
city: Seoul
country: Korea, Republic of
facility: Kandong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital/The Catholic University
Study officials:
affiliation: National Cancer Center, Korea
name: Il Ju Choi, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: International Agency for Research on Cancer
name: Rolando Herrero, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: