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

Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 10-day bismuth-based quadruple therapy; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 5224
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of, 620-739
    • Pusan National University Hospital
  • Chuncheon, Korea, Republic of, 24253
    • Hallym University Chuncheon Sacred Heart Hospital
  • Daegu, Korea, Republic of, 702-911
    • Kyungpook National University Hospital
  • Goyang, Korea, Republic of, 410-769
    • National Cancer Center
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of, 21431
    • Incheon St.Mary's Hospital/The Catholic University
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 05355
    • Kandong Sacred Heart Hospital
  • Seoul, Korea, Republic of, 156-861
    • Chung-Ang University Hospital
  • Uijeongbu, Korea, Republic of, 480-821
    • Uijeongbu St. Mary's Hospital/The Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; 10-day bismuth-based quadruple therapy for H. pylori positive subjects	Drug: 10-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; Other Names: Bismuth-based quadruple therapy
Placebo Comparator: Placebo group; Placebo for H. pylori positive subjects	Other: Placebo; Placebo for bismuth-based quadruple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of gastric cancer between the intervention and placebo groups	Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry	Up to 10 years After H. pylori eradication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastric dysplasia	Diagnosis of histologically confirmed gastric dysplasia	Up to 10 years After H. pylori eradication
Occurrence of adverse events caused by antibiotic treatment	Solicited/unsolicited adverse events	During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion
Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment	Assessed through record linkage or direct assessment during screening visits	Up to 10 years After H. pylori eradication
Mortality from gastric cancer	Cancer registry or other reports	Up to 10 years after eradication
All-cause mortality	Korean National Health Insurance records or other reports	Up to 10 years After H. pylori eradication
Modification of atrophy score	Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment	Up to 10 years After H. pylori eradication

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Pusan National University Hospital; Chonnam National University Hospital; Kyungpook National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; SMG-SNU Boramae Medical Center; International Agency for Research on Cancer; Kosin University Gospel Hospital; Chuncheon Sacred Heart Hospital; Kangdong Sacred Heart Hospital; Incheon St.Mary's Hospital/The Catholic University; Uijeongbu St. Mary's Hospital/The Catholic University
• Investigators: Study Director: Il Ju Choi, M.D., Ph.D., National Cancer Center, Korea; Principal Investigator: Rolando Herrero, M.D.,Ph.D, International Agency for Research on Cancer

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimated): April 11, 2014

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gastric cancer; Screening; Helicobacter pylori treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: NCCCTS13716; 1311240 (Other Grant/Funding Number: National Cancer Center, Korea)