NCT02968069

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

November 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
8.9 years until next milestone

Study Start

First participant enrolled

October 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

November 11, 2016

Last Update Submit

September 27, 2025

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions

    36 months

Study Arms (1)

Suspected gastric cancerous lesions

EXPERIMENTAL

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

Device: NBI

Interventions

NBIDEVICE

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)
Suspected gastric cancerous lesions

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xiaobo Li, MD.Ph.D

    Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaobo Li, MD.Ph.D

CONTACT

86-21-58752345lxb_1969@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 18, 2016

Study Start

October 10, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share