Early Gastric CancerNCT06152783
Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
An observational study of Early Gastric Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early Gastric Cancer
- How many people
- 578 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 21 Nov 2024
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard).
Who may be able to join
- Patients aged between 18 and 70 years;
- Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard);
- Patients who willing to provide written informed consent.
Who cannot join
- Patients with absolute contraindications to gastroscopy;
- Patients with advanced gastric cancer;
- Patients who cannot undergo histopathological examination;
- Patients who cannot be given general anesthesia;
- Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
- Patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.
Trial locations and contacts
1 site in 1 country.
About this study
This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.
Read the detailed description
Objectives:
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
Secondary Objectives
- Using histopathology as the gold standard, the diagnostic performance of CellTouch and ME-NBI in the diagnosis of early gastric cancer was compared and analyzed.
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in the diagnosis of early gastric cancer.
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.
- Conditions
- Early Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A group | The sequence of endoscopy in group A was as follows: white light endoscopy, ME-NBI endoscopy,Confocal laser endomicroscopy. | |
| B group | The sequence of endoscopy in group B was as follows: white light endoscopy, Confocal laser endomicroscopy, ME-NBI endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
The diagnostic properties of CellTouch include: sensitivity and specificity.
Measured: 30 min
Secondary outcomes (3)
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in early gastric cancer was compared and analyzed.
Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.
Measured: 30 min
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in early gastric cancer was compared and analyzed.
Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.
Measured: 30 min
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia was evaluated.
Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start21 Nov 2023 (estimated)
- Primary completion21 Nov 2024 (estimated)
- Study completion21 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi Hisky Medical Technology Co Ltd
- Responsible party
- Sponsor
- Investigators
- zhen-dong jin, phD, Principal investigator, Changhai Hospital shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152783
- Sponsor's protocol ID
- CH-2306
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastro-intestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7. doi: 10.21037/tgh.2020.04.02. eCollection 2022.
PubMed 35243116Han W, Kong R, Wang N, Bao W, Mao X, Lu J. Confocal Laser Endomicroscopy for Detection of Early Upper Gastrointestinal Cancer. Cancers (Basel). 2023 Jan 26;15(3):776. doi: 10.3390/cancers15030776.
PubMed 36765734Zhou YW, Zhang LY, Ding SN, Zhang AL, Zhu Y, Chen YX, Zhang QC, Sun LT, Yu JR. Hesitate between confocal laser endomicroscopy and narrow-band imaging: how to choose a better method in the detection of focal precancerous state of gastric cancer. Am J Transl Res. 2022 Jan 15;14(1):55-67. eCollection 2022.
PubMed 35173829Pang S, Yao H, Jiang C, Zhang Q, Lin R. Confocal Laser Endomicroscopy Can Improve the Diagnosis Rate and Range Assessment of Patients With Conflicting Chronic Atrophic Gastritis Results of White Light Endoscopic and Pathological Diagnosis. Front Oncol. 2022 Mar 24;12:809822. doi: 10.3389/fonc.2022.809822. eCollection 2022.
PubMed 35402229
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06152783
- Acronym / sponsor ID
- CH-2306
- Conditions
- Early Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Wuxi Hisky Medical Technology Co Ltd
- Study start
- 21 Nov 2023 (estimated)
- Primary completion
- 21 Nov 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 1 Dec 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 study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.
Detailed description
Objectives:
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
Secondary Objectives
- Using histopathology as the gold standard, the diagnostic performance of CellTouch and ME-NBI in the diagnosis of early gastric cancer was compared and analyzed.
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in the diagnosis of early gastric cancer.
- Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | – | –The sequence of endoscopy in group A was as follows: white light endoscopy, ME-NBI endoscopy,Confocal laser endomicroscopy. |
| B group | – | –The sequence of endoscopy in group B was as follows: white light endoscopy, Confocal laser endomicroscopy, ME-NBI endoscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard).
Key inclusion criteria (3 listed)
- Patients aged between 18 and 70 years;
- Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard);
- Patients who willing to provide written informed consent.
Key exclusion criteria (6 listed)
- Patients with absolute contraindications to gastroscopy;
- Patients with advanced gastric cancer;
- Patients who cannot undergo histopathological examination;
- Patients who cannot be given general anesthesia;
- Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
Time frame: 30 min
The diagnostic properties of CellTouch include: sensitivity and specificity.
3 secondary outcomes
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in early gastric cancer was compared and analyzed.
Time frame: 30 min
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in early gastric cancer was compared and analyzed.
Time frame: 30 min
Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia was evaluated.
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 35243116Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastro-intestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7. doi: 10.21037/tgh.2020.04.02. eCollection 2022.
- Background: PubMed 36765734Han W, Kong R, Wang N, Bao W, Mao X, Lu J. Confocal Laser Endomicroscopy for Detection of Early Upper Gastrointestinal Cancer. Cancers (Basel). 2023 Jan 26;15(3):776. doi: 10.3390/cancers15030776.
- Background: PubMed 35173829Zhou YW, Zhang LY, Ding SN, Zhang AL, Zhu Y, Chen YX, Zhang QC, Sun LT, Yu JR. Hesitate between confocal laser endomicroscopy and narrow-band imaging: how to choose a better method in the detection of focal precancerous state of gastric cancer. Am J Transl Res. 2022 Jan 15;14(1):55-67. eCollection 2022.
- Background: PubMed 35402229Pang S, Yao H, Jiang C, Zhang Q, Lin R. Confocal Laser Endomicroscopy Can Improve the Diagnosis Rate and Range Assessment of Patients With Conflicting Chronic Atrophic Gastritis Results of White Light Endoscopic and Pathological Diagnosis. Front Oncol. 2022 Mar 24;12:809822. doi: 10.3389/fonc.2022.809822. eCollection 2022.
- 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.
zhen-dong jin, phD principal investigator
Changhai Hospital shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Changhai Hospital at 1 site in China.
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 3 inclusion and 6 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 1 Dec 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 China. 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 wei an, doctor (13621719085, anweisusan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer. (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152783, which also lists 4 linked publications.
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 1 Dec 2023.