Actively Recruiting
Effect of Low-Dose Aspirin for Preventing Stomach Cancer After Endoscopic Removal of Early Gastric Lesions: A Randomized Controlled Trial
Led by National Cancer Center, Korea · Updated on 2024-12-27
1700
Participants Needed
10
Research Sites
632 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Korea
Lead Sponsor
I
Incheon St.Mary's Hospital/The Catholic University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of low-dose aspirin (100 mg daily) on preventing gastric cancer in patients who have early-stage gastric cancer or high-grade dysplasia and have undergone endoscopic submucosal dissection. This study focuses specifically on patients with negative Helicobacter pylori status or those who have successfully eradicated H. pylori. The study is a phase 3, multi-center, double-blind, randomized, placebo-controlled trial designed to provide clear evidence on aspirin's role in gastric cancer prevention, as previous studies lacked sufficient sample size or follow-up for cancer outcomes. Participants are randomly assigned to receive either a daily 100 mg aspirin tablet or a daily placebo tablet for 5 years. Both groups will be monitored during this treatment period to compare the incidence of gastric cancer between them. This long-term treatment approach aims to provide definitive data on whether aspirin can help prevent metachronous gastric cancer after endoscopic resection. During the study, participants will undergo regular assessments including clinical evaluations and monitoring for side effects or complications. Researchers will track the development of gastric cancer until the last enrolled patient completes the 5-year medication period. Safety monitoring and adherence checks are included to ensure participant well-being and accurate measurement of outcomes over the entire study duration.
CONDITIONS
Official Title
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 19 to 70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer
- Final pathology after endoscopic resection meets absolute or expanded criteria per Japanese Gastric Cancer Treatment guideline 2014
- Negative Helicobacter pylori status or successfully eradicated H. pylori
- Willingness to sign informed consent form
You will not qualify if you...
- Aspirin use for secondary prevention of cardiovascular or cerebrovascular diseases
- Regular aspirin use (more than 3 times a week) within 2 months before screening
- Use of anticoagulants or antiplatelet drugs for therapy
- History of gastrectomy
- Serious medical conditions hindering participation (severe heart dysfunction, liver cirrhosis, renal failure, COPD, bronchial asthma, uncontrolled infection)
- High risk for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, hemophilia, etc)
- Active peptic ulcer disease (patients with completely treated peptic ulcer may enroll)
- Diagnosis and active treatment of other organ cancers within 5 years (except carcinoma in situ and non-melanoma skin cancer)
- Non-curative resection of early gastric cancer after endoscopic resection
- Aspirin allergy or contraindication
- Pregnant or lactating women
- Alcoholism or drug abuse
- Unfit for study enrollment as evaluated by study physician
- Inability to provide informed consent
- Took less than 80% of 28-day run-in period medication
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Trial Site Locations
Total: 10 locations
1
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
2
Kosin University Gospel Hospital
Busan, South Korea, 49267
Actively Recruiting
3
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea, 24253
Actively Recruiting
4
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
5
National Cancer Center
Goyang, South Korea, 10408
Actively Recruiting
6
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
7
Incheon St.Mary's Hospital/The Catholic University
Incheon, South Korea, 21431
Actively Recruiting
8
Chung-Ang University Hospital
Seoul, South Korea, 06973
Actively Recruiting
9
SMG-SNU Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
10
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
Research Team
I
Il Ju Choi, M.D., Ph.D.
Y
Young-Il Kim, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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