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

Primary Purpose

Gastric Cancer, Helicobacter Pylori Infection

Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
10-day bismuth-based quadruple therapy
Placebo
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Helicobacter pylori treatment, Gastric cancer, Screening

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kosin University Gospel Hospital
  • Pusan National University Hospital
  • Hallym University Chuncheon Sacred Heart Hospital
  • Kyungpook National University Hospital
  • National Cancer Center
  • Chonnam National University Hospital
  • Incheon St.Mary's Hospital/The Catholic University
  • Kandong Sacred Heart Hospital
  • SMG-SNU Boramae Medical Center
  • Chung-Ang University Hospital
  • Uijeongbu St. Mary's Hospital/The Catholic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

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

Placebo for H. pylori positive subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of gastric dysplasia
Diagnosis of histologically confirmed gastric dysplasia
Occurrence of adverse events caused by antibiotic treatment
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
Assessed through record linkage or direct assessment during screening visits
Mortality from gastric cancer
Cancer registry or other reports
All-cause mortality
Korean National Health Insurance records or other reports
Modification of atrophy score
Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment

Full Information

First Posted
April 3, 2014
Last Updated
August 31, 2021
Sponsor
National Cancer Center, Korea
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT02112214
Brief Title
Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population
Acronym
HELPER
Official Title
Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Helicobacter Pylori Infection
Keywords
Helicobacter pylori treatment, Gastric cancer, Screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
10-day bismuth-based quadruple therapy for H. pylori positive subjects
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo for H. pylori positive subjects
Intervention Type
Drug
Intervention Name(s)
10-day bismuth-based quadruple therapy
Other Intervention Name(s)
Bismuth-based quadruple therapy
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for bismuth-based quadruple therapy
Primary Outcome Measure Information:
Title
The incidence of gastric cancer between the intervention and placebo groups
Description
Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry
Time Frame
Up to 10 years After H. pylori eradication
Secondary Outcome Measure Information:
Title
Incidence of gastric dysplasia
Description
Diagnosis of histologically confirmed gastric dysplasia
Time Frame
Up to 10 years After H. pylori eradication
Title
Occurrence of adverse events caused by antibiotic treatment
Description
Solicited/unsolicited adverse events
Time Frame
During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion
Title
Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment
Description
Assessed through record linkage or direct assessment during screening visits
Time Frame
Up to 10 years After H. pylori eradication
Title
Mortality from gastric cancer
Description
Cancer registry or other reports
Time Frame
Up to 10 years after eradication
Title
All-cause mortality
Description
Korean National Health Insurance records or other reports
Time Frame
Up to 10 years After H. pylori eradication
Title
Modification of atrophy score
Description
Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment
Time Frame
Up to 10 years After H. pylori eradication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rolando Herrero, M.D.,Ph.D
Organizational Affiliation
International Agency for Research on Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
620-739
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
ZIP/Postal Code
24253
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
702-911
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Incheon St.Mary's Hospital/The Catholic University
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Kandong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
156-861
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary's Hospital/The Catholic University
City
Uijeongbu
ZIP/Postal Code
480-821
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population

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