Undifferentiated Gastric CancerNCT02799420
Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
A study testing GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France and white light endoscopy (WLE) in people with Undifferentiated Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Undifferentiated Gastric Cancer
- What is being tested?
- GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France and white light endoscopy (WLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2016to 1 Sep 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery
Who cannot join
- Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.
- Conditions
- Undifferentiated Gastric Cancer
- Being tested
- GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France, white light endoscopy (WLE)
- Keywords
- confocal laser endomicroscopy, undifferentiated gastric cancer, target biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, FranceDevice
The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.
white light endoscopy (WLE)Device
The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy
| Study group | Role | What they receive |
|---|---|---|
| pCLE group | Experimental | The intervention group Receives: Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France |
| WLE group | Active comparator | The control group Receives: Device: white light endoscopy (WLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of cancer cells in biopsy samples
The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Measured: Day 3
Secondary outcomes (1)
The expression ratio of tumor marker in biopsy samples
The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start20 Jun 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799420
- Sponsor's protocol ID
- 4-2016-0257
- Status last verified
- Oct 2017
- First submitted
- 6 Jun 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
- ClinicalTrials.gov ID
- NCT02799420
- Acronym / sponsor ID
- 4-2016-0257
- Conditions
- Undifferentiated Gastric Cancer
- Keywords
- confocal laser endomicroscopy, undifferentiated gastric cancer, target biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pCLE group | Experimental | Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, FranceThe intervention group |
| WLE group | Active comparator | Device: white light endoscopy (WLE)The control group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery
Key exclusion criteria (1 listed)
- Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
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 |
|---|---|---|
| GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, FranceThe patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion. | Device | pCLE group |
| white light endoscopy (WLE)The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy | Device | WLE group |
Primary outcome
The percentage of cancer cells in biopsy samples
Time frame: Day 3
The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
1 secondary outcome
The expression ratio of tumor marker in biopsy samples
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Individual participant dataSharing planned: No. no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France and white light endoscopy (WLE) in people with Undifferentiated Gastric Cancer, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Oct 2017. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of cancer cells in biopsy samples (time frame: Day 3). 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 24 Oct 2017.