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Status unknownNCT06152783Updated Dec 1, 2023

Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study

An observational study in Early Gastric Cancer, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by Changhai Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
578
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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:

1. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.

Secondary Objectives

  1. 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.
  2. 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.
  3. 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.
02

Conditions studied

  • Early Gastric Cancer

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03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 578 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Browse Changhai Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients aged between 18 and 70 years;
  2. 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);
  3. Patients who willing to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with absolute contraindications to gastroscopy;
  2. Patients with advanced gastric cancer;
  3. Patients who cannot undergo histopathological examination;
  4. Patients who cannot be given general anesthesia;
  5. Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
  6. Patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
578 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 min

Secondary outcomes

  1. 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.

    Time frame: 30 min

  2. 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.

    Time frame: 30 min

  3. 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.

    Time frame: 30 min

07

Study locations

1 site
  • Changhai Hospital
    Shanghai, Shanghai Municipality 210000, China
08

References and documents

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 35243116 ↗
  • Han 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 36765734 ↗
  • Zhou 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 35173829 ↗
  • Pang 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Nov 2024, 12 months later.

Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 12 months is below that.

Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2023
First posted
Dec 1, 2023
StartEst.
Nov 21, 2023
Primary completionEst.
Nov 21, 2024
CompletionEst.
Nov 21, 2024
Last update
Dec 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06152783
Lead sponsor
Changhai Hospital
Collaborators
Wuxi Hisky Medical Technology Co Ltd
Responsible party
Sponsor
First posted
Dec 1, 2023
Start date
Nov 21, 2023 (estimated)
Primary completion
Nov 21, 2024 (estimated)
Completion
Nov 21, 2024 (estimated)
Last update
Dec 1, 2023

Study contacts

wei an, doctor
Contact
anweisusan@163.com
13621719085
zhen-dong jin, phD
principal investigator · Changhai Hospital shanghai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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