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

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ClinicalTrials.gov Identifier: NCT02112214
Recruitment Status : Active, not recruiting
First Posted : April 11, 2014
Last Update Posted : June 4, 2020
Sponsor:
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
Information provided by (Responsible Party):
Il Ju Choi, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Helicobacter Pylori Infection Drug: 10-day bismuth-based quadruple therapy Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: Bismuth-based quadruple therapy

Placebo Comparator: Placebo group
Placebo for H. pylori positive subjects
Other: Placebo
Placebo for bismuth-based quadruple therapy




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


Secondary Outcome Measures :
  1. Incidence of gastric dysplasia [ Time Frame: Up to 10 years After H. pylori eradication ]
    Diagnosis of histologically confirmed gastric dysplasia

  2. Occurrence of adverse events caused by antibiotic treatment [ Time Frame: During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion ]
    Solicited/unsolicited adverse events

  3. Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment [ Time Frame: Up to 10 years After H. pylori eradication ]
    Assessed through record linkage or direct assessment during screening visits

  4. Mortality from gastric cancer [ Time Frame: Up to 10 years after eradication ]
    Cancer registry or other reports

  5. All-cause mortality [ Time Frame: Up to 10 years After H. pylori eradication ]
    Korean National Health Insurance records or other reports

  6. Modification of atrophy score [ Time Frame: Up to 10 years After H. pylori eradication ]
    Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112214


Locations
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Korea, Republic of
Kosin University Gospel Hospital
Busan, Korea, Republic of, 49267
Pusan National University Hospital
Busan, Korea, Republic of, 620-739
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Korea, Republic of, 24253
Kyungpook National University Hospital
Daegu, Korea, Republic of, 702-911
National Cancer Center
Goyang, Korea, Republic of, 410-769
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Incheon St.Mary's Hospital/The Catholic University
Incheon, Korea, Republic of, 21431
Kandong Sacred Heart Hospital
Seoul, Korea, Republic of, 05355
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 07061
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-861
Uijeongbu St. Mary's Hospital/The Catholic University
Uijeongbu, Korea, Republic of, 480-821
Sponsors and Collaborators
National Cancer Center, Korea
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
Investigators
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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
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Responsible Party: Il Ju Choi, Head of Gastric Cancer Cencer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02112214    
Other Study ID Numbers: NCCCTS13716
1311240 ( Other Grant/Funding Number: National Cancer Center, Korea )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Il Ju Choi, National Cancer Center, Korea:
Helicobacter pylori treatment
Gastric cancer
Screening
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents