Clinical trial · Interventional
Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions
NCT05977478CI-TRIAL-00068526unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECTRA IMDx™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPECTRA IMDx™.
- description
- 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.
- interventionNames
- Device: SPECTRA IMDx™
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 18 moths
- description
- 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™.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.