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Effect of Helicobacter pylori eradication on gastric cancer prevention in Korea: A randomized controlled clinical trial

Status Approved

First Submitted Date

2014/09/26
Registered Date

2014/10/23
Last Updated Date

2020/02/05

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001262
Unique Protocol ID	NCCCTS-13-716
Public/Brief Title	Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population
Scientific Title	Effect of Helicobacter pylori eradication on gastric cancer prevention in Korea: A randomized controlled clinical trial
Acronym	HELPER (Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population)
MFDS Regulated Study	Yes
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT02112214
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	NCCCTS-13-716
Approval Date	2013-12-16
Institutional Review Board Name	Institutional Review Board of National Cancer Center
Institutional Review Board Address	323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-920-0425
Data Monitoring Committee	Yes Data Safety and Monitoring Board

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Il Ju Choi
Title	M.D., Ph.D.
Telephone	+82-31-920-2282
Affiliation	National Cancer Center
Address	323 Ilsan-ro, Ilsandong-gu, Ilsandong-gu, Goyang, Gyeonggi, 10408, Republic of Korea
Contact Person for Public Queries
Name	Young-Il Kim
Title	M.D.
Telephone	+82-31-920-2282
Affiliation	National Cancer Center
Address	323 Ilsan-ro, Ilsandong-gu, Ilsandong-gu, Goyang, Gyeonggi, 10408, Republic of Korea
Contact Person for Updating Information
Name	Young-Il Kim
Title	M.D.
Telephone	+82-31-920-1712
Affiliation	NCC Hospital
Address	323 Ilsan-ro, Ilsandong-gu, Ilsandong-gu, Goyang, Gyeonggi, 10408, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 12
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-06-16 Actual
Target Number of Participant	5224
Primary Completion Date	2029-12-31 , Anticipated
Study Completion Date	2029-12-31 , Anticipated
Name of Study	National Cancer Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-06-26 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyungpook National University Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-06-16 ,
Recruitment Status by Participating Study Site 3
Name of Study	Pusan National University Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-06-17 ,
Recruitment Status by Participating Study Site 4
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-07-04 ,
Recruitment Status by Participating Study Site 5
Name of Study	Chonnam National University Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2014-07-11 ,
Recruitment Status by Participating Study Site 6
Name of Study	The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2015-01-26 ,
Recruitment Status by Participating Study Site 7
Name of Study	Kyungpook National University Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2015-07-01 ,
Recruitment Status by Participating Study Site 8
Name of Study	Kangdong Sacred Heart Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2015-04-22 ,
Recruitment Status by Participating Study Site 9
Name of Study	The Catholic University of Korea, Incheon St. Mary's Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2016-04-20 ,
Recruitment Status by Participating Study Site 10
Name of Study	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-04-24 ,
Recruitment Status by Participating Study Site 11
Name of Study	Hallym University Medical Center- Chuncheon
Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-05-19 ,
Recruitment Status by Participating Study Site 12
Name of Study	Kosin University Gospel Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-07-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Cancer Center
Organization Type	Medical Institute
Project ID	1311240
2. Source of Monetary/Material Support
Organization Name	National Cancer Center
Organization Type	Medical Institute
Project ID	1510530
3. Source of Monetary/Material Support
Organization Name	National Cancer Center
Organization Type	Medical Institute
Project ID	1810610
4. Source of Monetary/Material Support
Organization Name	National Cancer Center
Organization Type	Medical Institute
Project ID	1910370

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	National Cancer Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	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 Summary Information

Lay Summary

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&#37;, &gt;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.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Phase3
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	- Subjects who are H. pylori positive will randomly be assigned to either the intervention group or the placebo group. a. Intervention group 10-day bismuth-based quadruple therapy for H. pylori positive subjects (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) - Participants with no evidence of H. pylori infection will constitute the “Negative Group”and will be followed up without treatment. b.Placebo group Placebo for H. pylori positive subjects
Number of Arms	2
Arm 1	Arm Label Intervention group
	Target Number of Participant 2612
	Arm Type Experimental
	Arm Description Bismuth 300 mg (4 times a day) + lansoprazole 30 mg (twice a day) + metronidazole 500 mg (3 times a day) + tetracycline 500 mg (4 times a day) for 10 days
Arm 2	Arm Label Placebo group
	Target Number of Participant 2612
	Arm Type Placebo comparator
	Arm Description Placebo for same schedules with treatment group

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (A00-B99)Certain infectious and parasitic diseases (B98.0)Helicobacter pylori[H.pylori] as the cause of diseases classified to other chapters Helicobacter pylori infection
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 40Year~65Year
	Description - 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
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	The incidence of gastric cancer between the intervention and placebo groups
Timepoint	Up to 10 years After H. pylori eradication
Secondary Outcome(s) 1
Outcome	Incidence of gastric dysplasia
Timepoint	Up to 10 years After H. pylori eradication
Secondary Outcome(s) 2
Outcome	Occurrence of adverse events caused by antibiotic treatment
Timepoint	During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion
Secondary Outcome(s) 3
Outcome	Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment
Timepoint	Up to 10 years After H. pylori eradication
Secondary Outcome(s) 4
Outcome	Mortality from gastric cancer
Timepoint	Up to 10 years After H. pylori eradication
Secondary Outcome(s) 5
Outcome	All-cause mortality
Timepoint	Up to 10 years After H. pylori eradication
Secondary Outcome(s) 6
Outcome	Modification of atrophy score
Timepoint	Up to 10 years After H. pylori eradication

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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