NCT05977478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 4, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

July 7, 2023

Last Update Submit

July 26, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

SPECTRA IMDx™.

EXPERIMENTAL

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™

Interventions

SPECTRA IMDx™DEVICE

In this study, SPECTRA IMDxTM system will be used to capture the Raman spectra to correlate to histopathology results and mass spectrometry profiling results.

SPECTRA IMDx™.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Guowei Kim, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guowei Kim, MBBS

CONTACT

+65-67725555guo_wei_kim@nuhs.edu.sg

Bok Yan So, MBChB

CONTACT

+65-67725555sursbyj@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2023

First Posted

August 4, 2023

Study Start

October 27, 2022

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

August 4, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)