NCT05631015

Brief Summary

The purpose of this study is to develop and validate a clinical decision support system based on automated algorithms. This system can use natural language processing to extract data from patients' endoscopic reports and pathological reports, identify patients' disease types and grades, and generate guidelines based follow-up or treatment recommendations

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 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

January 1, 2012

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

10.8 years

First QC Date

November 19, 2022

Last Update Submit

November 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The diagnostic accuracy of gastric diseases with deep learning algorithm

    The diagnostic accuracy of gastric diseases with deep learning algorithm

    12 month

  • The accuracy of recommentions for different disease with deep learning algorithm

    The accuracy of recommentions for different disease with deep learning algorithm

    12 month

Secondary Outcomes (5)

  • The diagnostic sensitivity of gastric diseases with deep learning algorithm

    12 month

  • The diagnostic specificity of gastric diseases with deep learning algorithm

    12 month

  • The diagnostic positive predictive value of gastric diseases with deep learning algorithm

    12 month

  • The diagnostic negative predictive value of gastric diseases with deep learning algorithm

    12 month

  • The F-score of gastric diseases with deep learning algorithm

    12 month

Study Arms (1)

Artificial Intelligence support decision group

According the endoscopic reports and pathological reports, the decision support system recognise patients' disease types and grades, and generate guidelines based survilliance or treatment recommendations.

Other: AI recongnize disease and generate recommendations

Interventions

According the endoscopic reports and pathological reports, the decision support system recognise patients' disease types and grades, and generate guidelines based survilliance or treatment recommendations.

Artificial Intelligence support decision group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who came to Qilu Hospital of Shandong University and received endoscopy examination but not therapeutic endoscopy

You may qualify if:

  • Patients aged 18 - 80 years
  • Patients underwent endoscopic examination

You may not qualify if:

  • Patients with the contraindications to endoscopic examination
  • Patients with imcomplete examination information
  • Patients undergo endoscopy for therapy
  • Patients have history of upper gastrointestinal surgery
  • Patients with duodenal or Laryngeal neoplasms
  • Patients with gastrointestinal submucosal tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Gastritis, AtrophicStomach Neoplasms

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

November 19, 2022

First Posted

November 30, 2022

Study Start

January 1, 2012

Primary Completion

October 31, 2022

Study Completion

December 31, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations