Gastric CancerNCT05977478
Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions
A study testing SPECTRA IMDx™ in people with Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SPECTRA IMDx™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Oct 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Guowei Kim, MBBS, +65-67725555, guo_wei_kim@nuhs.edu.sg
About this study
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- SPECTRA IMDx™
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SPECTRA IMDx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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™.
Measured: 18 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start27 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Endofotonics Pte Ltd
- Responsible party
- Sponsor
- Investigators
- Guowei Kim, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977478
- Sponsor's protocol ID
- 2022/00489
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions
- ClinicalTrials.gov ID
- NCT05977478
- Acronym / sponsor ID
- 2022/00489
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Endofotonics Pte Ltd
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPECTRA IMDx™. | Experimental | Device: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- They are aged 21 years and above
- They will be undergoing upper gastrointestinal endoscopy for any of the following:
- They must be mentally competent.
- They must be willing and able to comply with all study procedures.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SPECTRA IMDx™. |
Primary outcome
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™.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guowei Kim, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECTRA IMDx™ in people with Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guowei Kim, MBBS (+65-67725555, guo_wei_kim@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 18 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.