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Not yet recruitingNCT02968069Updated Oct 2, 2025

A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

An interventional study of NBI in Early Gastric Cancer, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Read the detailed description

Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

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Conditions studied

  • Early Gastric Cancer

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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 300 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

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

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Suspected of having a cancerous lesions
  • The age of patients is from 40-80 years
  • Patients must undergo esophagogastroduodenoscopy

Exclusion criteria

Exclusion Criteria:

  • Clinical diagnosis of advanced gastric cancer
  • Acute upper gastrointestinal bleeding
  • Severe systemic diseases
  • Refuse to attend the study
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Suspected gastric cancerous lesions

    Magnifying endoscopy with NBI would be conducted for every patient included in our study

    Device: NBI

Interventions

  • DeviceNBI

    Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.

    Also known as: Evis Lucera system (CV-260, Olympus Inc, Japan), high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan), magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)

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What researchers measure

Primary outcomes

  1. Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions

    Time frame: 36 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02968069
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Putuo District Center Hospital, Shanghai MCC worker hospital
Responsible party
Xiaobo Li (Professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Nov 18, 2016
Start date
Oct 10, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Oct 2, 2025

Study contacts

Xiaobo Li, MD.Ph.D
Contact
lxb_1969@163.com
86-21-58752345
Xiaobo Li, MD.Ph.D
principal investigator · Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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