Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04869618
Eligibility Criteria:
Inclusion Criteria:
1. Known diagnosis of gastric dysplasia with visible lesion or early gastric cancer amenable to gastric ER (EMR or ESD); diagnosis made based on biopsy from gastroscopy performed within past six months
2. Age 21 to 90 years (selected age range based on demographic of patients managed at Changi General Hospital)
3. Ability to provide informed consent
Exclusion Criteria:
1. Subjects without mental capacity, refusal to provide consent, incarcerated status, pregnant subjects.
2. Subjects with advanced gastric cancer not amenable to endoscopic resection
3. Subjects with bleeding disorders, such as haemophilia, in whom ER and biopsies are contraindicated.
4. Subjects with active bleeding or coagulopathy precluding ER and biopsies.
5. Subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
6. Subjects on regular anti-platelet medications except aspirin or anti-coagulants must be able to undergo adequate washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04869618
Study Brief:
Protocol Section:
NCT04869618