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Clinical Trials/NCT05977478
NCT05977478
Recruiting
Not Applicable

Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions

National University Hospital, Singapore1 site in 1 country25 target enrollmentOctober 27, 2022
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
National University Hospital, Singapore
Enrollment
25
Locations
1
Primary Endpoint
Correlating tissue biochemical composition with the Raman spectra and histopathologic results to differentiate between the gastric disease states based on distinct features in the biochemical composition of pre-cancerous / cancerous lesions.
Status
Recruiting
Last Updated
2 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
October 27, 2022
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • They are aged 21 years and above
  • They will be undergoing upper gastrointestinal endoscopy for any of the following:
  • 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.
  • They must be mentally competent.
  • They must be willing and able to comply with all study procedures.

Exclusion Criteria

  • Subjects with bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
  • Subjects with active bleeding or coagulopathy precluding biopsies.
  • Pregnant subjects.
  • The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
  • 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

Outcomes

Primary Outcomes

Correlating tissue biochemical composition with the Raman spectra and histopathologic results to differentiate between the gastric disease states based on distinct features in the biochemical composition of pre-cancerous / cancerous lesions.

Time Frame: 18 moths

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™.

Study Sites (1)

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