Ulcerative Colitis Mayo Score With Artificial Intelligence

Sponsor
Third Military Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05336773
Collaborator
(none)
500
1
14
35.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this project, artificial intelligence was used to colonoscopic images of patients with ulcerative colitis with different disease activity levels and classify them according to the evaluation standard Mayo score to assist endoscopists in identifying disease activity levels of patients with ulcerative colitis during colonoscopy. It can help clinical endoscopists to accurately identify, and the visualization technology of artificial intelligence category response map can comprehensively display the areas with high importance for deep network classification results, and visualize the experimental lesion sites, thus effectively verifying the reliability and interpretability of deep network. This study can provide strong support for accurate identification of disease activity in clinical ulcerative colitis, effectively reduce the workload of clinicians, and provide a convenient, effective and practical clinical teaching tool.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Research on Artificial Intelligence-based Mayo Score Recognition System for Disease Activity Degree of Ulcerative Colitis Under Digestive Endoscopy
    Anticipated Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The accuracy of deep learning model in the training and validation datasets assessment of Mayo score in ulcerative colitis patients. [Through study completion, an average of 1 year.]

      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.

    Secondary Outcome Measures

    1. The accuracy and time efficiency of endoscopists assessment of Mayo score in ulcerative colitis patients. [Through study completion, an average of 1 year.]

      The dataets were randomly assigned to endoscopists. All endoscopists were trained in diagnostic studies, finished both clinical and specific endoscopic training, and were not involved in the enrollment and labeling of the patients and images. During the comparison test, all data were randomized and deidentified beforehand. The average time spent by 10 endoscopists in diagnosing the test dataset in the deep learning model and the number of correct cases were analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Subjects were 18-72 years old, male and female;

    2. Clinical diagnosis of ulcerative colitis;

    3. The subjects underwent colonoscopy and the colonoscopy report was complete.

    Exclusion Criteria:
    1. Subjects are younger than 18 years old or older than 72 years old;

    2. Subjects underwent colectomy, ileostomy, colostomy, ileostomy, or other intestinal resection;

    3. subjects with ambiguous diagnosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Third Military Medical University Chongqing Chongqing China 400042

    Sponsors and Collaborators

    • Third Military Medical University

    Investigators

    • Study Director: Yanling Wei, Professor, Third Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanling Wei, Associate chief physician, M D., Third Military Medical University
    ClinicalTrials.gov Identifier:
    NCT05336773
    Other Study ID Numbers:
    • TMMU-DP--002
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2022