Ulcerative Colitis Mayo Score With Artificial Intelligence

Ulcerative Colitis Clinical Trial

Official title:

Research on Artificial Intelligence-based Mayo Score Recognition System for Disease Activity Degree of Ulcerative Colitis Under Digestive Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05336773
• Other study ID #: TMMU-DP--002
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Third Military Medical University
• Contact: Yanling Wei, professor
• Phone: +8615310354666
• Email: lingzi016[@]tmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Colonoscopy
• Deep Learning
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
China	Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The accuracy and time efficiency of endoscopists assessment of Mayo score in ulcerative colitis patients.	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.	Through study completion, an average of 1 year.