Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population

Gastric Cancer Clinical Trial

— HELPER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02112214
• Other study ID #: NCCCTS13716
• Secondary ID: 1311240
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5224
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Helicobacter Pylori Infection
• Stomach Neoplasms

Intervention

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:
• Placebo
Placebo for bismuth-based quadruple therapy

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Incheon St.Mary's Hospital/The Catholic University	Incheon
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Kandong Sacred Heart Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Uijeongbu St. Mary's Hospital/The Catholic University	Uijeongbu

Sponsors (12)

Lead Sponsor

Collaborator

National Cancer Center, Korea

Chonnam National University Hospital, Chuncheon Sacred Heart Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Incheon St.Mary's Hospital/The Catholic University, International Agency for Research on Cancer, Kangdong Sacred Heart Hospital, Kosin University Gospel Hospital, Kyungpook National University Hospital, Pusan National University Hospital, SMG-SNU Boramae Medical Center, Uijeongbu St. Mary's Hospital/The Catholic University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of gastric dysplasia	Diagnosis of histologically confirmed gastric dysplasia	Up to 10 years After H. pylori eradication
Secondary	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
Secondary	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
Secondary	Mortality from gastric cancer	Cancer registry or other reports	Up to 10 years after eradication
Secondary	All-cause mortality	Korean National Health Insurance records or other reports	Up to 10 years After H. pylori eradication
Secondary	Modification of atrophy score	Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment	Up to 10 years After H. pylori eradication