Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977478
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-07
Brief Title:
Characterization of Tissue Biochemical Composition in Gastric PrecancerousCancerous Lesions
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Characterization of Tissue Biochemical Composition in Gastric PrecancerousCancerous Lesions
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 precancerouscancerous 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 hospitals standard procedures No follow-up is needed in this study
During endoscopy the endoscopist will first locate the precancerouscancerous 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 hospitals standard procedures No follow-up is needed in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None