Using low-dose aspirin to prevent gastric cancer in early gastric cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effect of low-dose aspirin (100 mg) on preventing gastric cancer in patients who have undergone endoscopic submucosal dissection for early gastric cancer and have a negative H. pylori status. The trial is designed as a multi-center, double-blind, placebo-controlled intervention to assess the long-term cancer prevention effects of aspirin. It aims to address the limitations of previous studies by focusing specifically on gastric cancer prevention rather than cardiovascular outcomes. Participants will be monitored for the development of metachronous gastric cancer following their treatment.

Why it matters

Who can join: the full rules

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%

Where it's running

• Pusan National University Hospital
  Busan, South Korea Recruiting
• Kosin University Gospel Hospital
  Busan, South Korea Recruiting
• Hallym University Chuncheon Sacred Heart Hospital
  Chuncheon, South Korea Recruiting
• Kyungpook National University Chilgok Hospital
  Daegu, South Korea Recruiting
• National Cancer Center
  Goyang, South Korea Recruiting
• Chonnam National University Hospital
  Gwangju, South Korea Recruiting

Study contacts

• Study coordinator: Il Ju Choi, M.D., Ph.D.
• Email: cij1224@ncc.re.kr
• Phone: +82-31-920-2282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.