NCT04563416

Brief Summary

Previous prospective randomized controlled study demonstrated higher accuracy rate of diagnosing early gastric cancers by Magnifying image-enhanced endoscopy than conventional white-light endoscopy. Nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner. we developed a new computer-aided system to assist endoscopists in identifying early gastric cancers in magnifying optical enhancement images.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

September 22, 2020

Last Update Submit

September 22, 2020

Conditions

Artificial IntelligenceOptical Enhancement EndoscopyMagnifying Endoscopy

Outcome Measures

Primary Outcomes (1)

  • the diagnosis efficiency of the computer-assist diagnosis tool

    the sensitivity, specificity and accuracy of the computer-assist diagnosis tool

    12 months

Study Arms (1)

Patients who need undergo magnifying endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients suspected of early gastric cancer and receive optical magnifying OE endoscopy examination.

You may qualify if:

  • patients receive optical magnifying OE endoscopy examination

You may not qualify if:

  • Patients with advanced cancer, lymphoma,active stage of ulcer and artificial ulcer after ESD were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

  • Ma M, Li Z, Yu T, Liu G, Ji R, Li G, Guo Z, Wang L, Qi Q, Yang X, Qu J, Wang X, Zuo X, Ren H, Li Y. Application of deep learning in the real-time diagnosis of gastric lesion based on magnifying optical enhancement videos. Front Oncol. 2022 Aug 5;12:945904. doi: 10.3389/fonc.2022.945904. eCollection 2022.

    PMID: 35992850DERIVED

Study Officials

  • Yanqing Li, PHD

    Study Principal Investigator Qilu Hospital, Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, PHD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 24, 2020

Study Start

July 10, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

CN(1)