Status:
UNKNOWN
Validation of an Artificial Intelligence System Based on Raman Spectroscopy for Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer
Lead Sponsor:
Changi General Hospital
Conditions:
Gastric Dysplasia
Gastric Intestinal Metaplasia
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
Early detection and treatment of gastric premalignant lesion and early gastric cancer (EGC) have been proposed to improve outcomes of gastric cancer. Gastric dysplasia is a premalignant lesion and the...
Detailed Description
This is a prospective, single-centre study designed to evaluate the diagnostic performance of SPECTRA IMDx for real-time characterisation of gastric dysplasia and early gastric cancer for patients und...
Eligibility Criteria
Inclusion
- 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
- Age 21 to 90 years (selected age range based on demographic of patients managed at Changi General Hospital)
- Ability to provide informed consent
Exclusion
- Subjects without mental capacity, refusal to provide consent, incarcerated status, pregnant subjects.
- Subjects with advanced gastric cancer not amenable to endoscopic resection
- Subjects with bleeding disorders, such as haemophilia, in whom ER and biopsies are contraindicated.
- Subjects with active bleeding or coagulopathy precluding ER and biopsies.
- Subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04869618
Start Date
May 1 2021
End Date
March 1 2023
Last Update
May 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Changi General Hospital
Singapore, Singapore, 529889