NCT04214990RecruitingPhase 3
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1700 (estimated)
- First submitted
- 29 Dec 2019
- Start date
- 15 Feb 2020
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04214990
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1700
- From 15 Feb 2020 to the primary completion date, 31 Mar 2031
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Alcoholism, drug abuse
- Patients who took a 28-day run-in-period medication less than 80%
Other illness
- 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
Other
- Pregnant or lactating women
- Inadequate patients for study enrollment according to the evaluation of the study physician
- Inability to provide an informed consent
Who the study is looking for
- 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
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Hallym University Chuncheon Sacred Heart Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang | South Korea | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Incheon St.Mary's Hospital/The Catholic University Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| SMG-SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.