Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions
NCT ID: NCT05977478
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2022-10-27
2024-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SPECTRA IMDx™.
During endoscopy, the endoscopist will first locate the precancerous/cancerous gastric 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. They will be undergoing upper gastrointestinal endoscopy for any of the following:
1. Current or known history of gastric dysplasia and gastric cancer, or
2. Endoscopic surveillance after previous endoscopic or surgical resection for gastric dysplasia or gastric cancer.
3. They must be mentally competent.
4. They must be willing and able to comply with all study procedures.
Exclusion Criteria
2. Subjects with active bleeding or coagulopathy precluding biopsies.
3. Pregnant subjects.
4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
5. Subjects with other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results or would make the subject unsuitable for entry into the study
21 Years
ALL
No
Sponsors
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Endofotonics Pte Ltd
INDUSTRY
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Guowei Kim, MBBS
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/00489
Identifier Type: -
Identifier Source: org_study_id
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