|

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

RECRUITINGPhase 3Sponsored by National Cancer Center, Korea
Actively Recruiting
PhasePhase 3
SponsorNational Cancer Center, Korea
Started2020-02-15
Est. completion2031-03-31
Eligibility
Age19 Years – 70 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 19 Years – 70 YearsHealthy volunteers accepted
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%

Conditions3

AspirinCancerGastric Cancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.