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Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population

NCT ID: NCT02112214

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer Helicobacter Pylori Infection

Keywords

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Helicobacter pylori treatment Gastric cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

10-day bismuth-based quadruple therapy for H. pylori positive subjects

Group Type ACTIVE_COMPARATOR

10-day bismuth-based quadruple therapy

Intervention Type DRUG

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

Placebo group

Placebo for H. pylori positive subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo for bismuth-based quadruple therapy

Interventions

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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

Intervention Type DRUG

Placebo

Placebo for bismuth-based quadruple therapy

Intervention Type OTHER

Other Intervention Names

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Bismuth-based quadruple therapy

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Agency for Research on Cancer

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Uijeongbu St. Mary's Hospital/The Catholic University

UNKNOWN

Sponsor Role collaborator

Kangdong Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Incheon St.Mary's Hospital/The Catholic University

UNKNOWN

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Kosin University Gospel Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Il Ju Choi

Head of Gastric Cancer Cencer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Il Ju Choi, M.D., Ph.D.

Role: STUDY_DIRECTOR

National Cancer Center, Korea

Rolando Herrero, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

Locations

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Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

National Cancer Center

Goyang, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Incheon St.Mary's Hospital/The Catholic University

Incheon, , South Korea

Site Status

Kandong Sacred Heart Hospital

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Uijeongbu St. Mary's Hospital/The Catholic University

Uijeongbu-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1311240

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCCCTS13716

Identifier Type: -

Identifier Source: org_study_id