NCT04384575

Brief Summary

This study aims to construct a real-time quality monitoring system based on artificial intelligence technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

May 8, 2020

Last Update Submit

November 28, 2023

Conditions

Gastric Cancer

Keywords

gastric cancerartificial intelligenceendoscopy

Outcome Measures

Primary Outcomes (3)

  • Accuracy

    Calculate the accuracy of AI's judgment on images

    2020.2.22-2020.7.1

  • Sensitivity

    number of images in which AI correctly diagnosed positive/all images with positive

    2020.2.22-2020.7.1

  • Specificity

    number of images in which AI correctly diagnosed negative/all images negative

    2020.2.22-2020.7.1

Interventions

blind spotsDIAGNOSTIC_TEST

missed part during map the entire stomach through endoscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who meet the criteria for gastroscopy examination.

You may qualify if:

  • Patiens aged 18 years or above undergoing gastroscopy；
  • Be able to read, understand and sign informed consent；

You may not qualify if:

  • Patients with absolute contraindications to endoscopy examination;
  • pregnant women;
  • previous history of gastric surgery;
  • the researcher considers that the subject is not suitable for clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Haidian, 100142, China

Location

Related Publications (1)

  • Yuan P, Ma ZH, Yan Y, Li SJ, Wang J, Wu Q. Artificial Intelligence-Based Classification of Anatomical Sites in Esophagogastroduodenoscopy Images. Int J Gen Med. 2024 Dec 12;17:6127-6138. doi: 10.2147/IJGM.S481127. eCollection 2024.

    PMID: 39691834DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Diagnostic Errors

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DiagnosisMedical ErrorsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Qi Wu, MD.

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PHD

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

February 22, 2020

Primary Completion

January 13, 2022

Study Completion

May 1, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

CN(1)