Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions

July 26, 2023 updated by: National University Hospital, Singapore
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. They are aged 21 years and above

  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:

  1. Subjects with bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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™.
18 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Endofotonics Pte Ltd

Investigators

  • Principal Investigator: Guowei Kim, MBBS, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/00489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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