NCT05977478

Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study site will be National University Hospital.

Detailed description

This is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study site will be National University Hospital. Subjects will be patients with current or known history of gastric dysplasia and gastric cancer, or endoscopic surveillance after previous endoscopic or surgical resection for gastric dysplasia or gastric cancer, for which upper gastrointestinal endoscopy is indicated. Patients who meet the study criteria and have consented to participate in the study will undergo upper gastrointestinal endoscopy examination as per standard practice. During endoscopy, the endoscopist will first locate the precancerous/cancerous lesions using HD-WLE. Upon location of the lesion, the endoscopist will use the SPECTRA IMDx™ probe to capture the Raman spectra from the lesion and its adjacent normal mucosa. Two biopsies will be obtained from the lesion, and two biopsies from adjacent normal mucosa at the exact sites where the SPECTRA IMDx probe has been placed. One biopsy each from the lesion and from normal mucosa will be sent for histopathologic examination. Another biopsy each from the lesion and normal mucosa will be snap-freeze, stored in liquid nitrogen immediately, and transferred to mass spectrometry service provider for lipidomic and proteomic profiling. Histopathology results and mass spectrometry profiling results will be correlated to Raman spectra. Subjects will receive the standard care assessments throughout the study according to the hospital's standard procedures. No follow-up is needed in this study.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	SPECTRA IMDx™	In this study, SPECTRA IMDxTM system will be used to capture the Raman spectra to correlate to histopathology results and mass spectrometry profiling results.

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: Singapore