Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions (NCT05977478) | Clinical Trial Compass
UnknownNot Applicable
Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions
Singapore25 participantsStarted 2022-10-27
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
. 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