Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
NCT ID: NCT01678027
Last Updated: 2023-11-09
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
1838 participants
INTERVENTIONAL
2004-11-30
2035-12-31
Brief Summary
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Detailed Description
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Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo for LAC triple therapy
Placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
LAC triple therapy
PPI (Lansoprazole), Clarithromycin, Amoxicilline
LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
Interventions
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Placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent should be signed
Exclusion Criteria
* Other malignancy within the past 5 years
* Hereditary cancer family member (HNPCC, FAP)
* Peptic ulcer history
* Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
* H. pylori eradication treatment history
* Previous serious side effect to antibiotics
* Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
* Pregnant or nursing women
* Psychiatric disorder that would preclude compliance, alcoholics
* Refuse informed consent
40 Years
65 Years
ALL
Yes
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Il Ju Choi
M.D., Ph.D
Principal Investigators
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Il Ju Choi, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Korea
Locations
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National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
Countries
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References
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Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, Joo J. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666.
Other Identifiers
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NCCCTS04-103
Identifier Type: -
Identifier Source: org_study_id
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