NCT05336773

Brief Summary

This project will use deep learning to classify colonoscopy images of different severity of ulcerative colitis, so as to assist clinicians in the accurate diagnosis of ulcerative colitis.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

February 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

February 27, 2022

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The accuracy of deep learning model in the training and validation datasets assessment of Mayo score in ulcerative colitis patients.

    In the training and validation datasets, we plotted the AUC (area under curve) for Mayo 0, Mayo 1, Mayo 2, and Mayo 3 to evaluate our model objectively.

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • The accuracy and time efficiency of endoscopists assessment of Mayo score in ulcerative colitis patients.

    Through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years - 72 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The images were retrieved from the endoscopy database of Army Medical Center of PLA and obtained from the colonoscopy of patients with ulcerative colitis who met the inclusion criteria. The data images were used to establish and verify the model of ai-assisted recognition system.

You may qualify if:

  • Subjects were 18-72 years old, male and female;
  • Clinical diagnosis of ulcerative colitis;
  • The subjects underwent colonoscopy and the colonoscopy report was complete.

You may not qualify if:

  • Subjects are younger than 18 years old or older than 72 years old;
  • Subjects underwent colectomy, ileostomy, colostomy, ileostomy, or other intestinal resection;
  • subjects with ambiguous diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

  • Qi J, Ruan G, Ping Y, Xiao Z, Liu K, Cheng Y, Liu R, Zhang B, Zhi M, Chen J, Xiao F, Zhao T, Li J, Zhang Z, Zou Y, Cao Q, Nian Y, Wei Y. Development and validation of a deep learning-based approach to predict the Mayo endoscopic score of ulcerative colitis. Therap Adv Gastroenterol. 2023 May 22;16:17562848231170945. doi: 10.1177/17562848231170945. eCollection 2023.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yanling Wei, Professor

    Third Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Yanling Wei, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician, M D.

Study Record Dates

First Submitted

February 27, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations