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Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients

RecruitingPhase 3Ages 19 Years - 70 YearsAllNational Cancer Center, Korea
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In plain words

What the trial is, and whether it could suit you

This study aimed to investigate the effect of low-dose (100 mg) asprin on the prevention of gastric cancer in the early gastric cancer patients with negative H. pylori status who underwent endoscopic submucosal dissection.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Men and women aged 19-70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer (category 4 \[non-invasive high grade neoplasm\] or category 5 \[invasive neoplasia\] according to the Vienna classification of gastrointestinal epithelial neoplasia \[Schlemper RJ, et al. Gut 2000;47:251-255.\]) * Final pathological results after endoscopic resection met the absolute or expanded criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4) * Patients who had negative H. pylori status or those who eradicated H. pylori status * Willingness to sign an informed consent form Exclusion Criteria: * Patients who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases * Regular aspirin uses (more than 3 times a week) with 2 months before screening visit * Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose * Previous gastrectomy history * Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection) * High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc) * Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled) * Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years * Non-curative resection of early gastric cancer after endoscopic resection * Aspirin allergy or contraindication of aspirin use * Pregnant or lactating women * Alcoholism, drug abuse * Inadequate patients for study enrollment according to the evaluation of the study physician * Inability to provide an informed consent * Patients who took a 28-day run-in-period medication less than 80%
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What it tests

  • Aspirin 100mg
  • Placebo oral tablet
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Where

10 sites
Pusan National University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Incheon St.Mary's Hospital/The Catholic University
Incheon, South Korea
Chung-Ang University Hospital
Seoul, South Korea

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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