Accuracy of Computer-aided (CADx) System in Real-time Characterization of Colorectal Ulcerative Diseases

NCT06207825 | Not Yet Recruiting DMC

• 1 other identifier: NFEC-2023-312
• Study Type: observational
• Target: 495
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to test the diagnostic accuracy of the newly developed CADx system in predicting the histopathology of colorectal ulcers when compared to expert endoscopists. The main question it aims to answer are to demonstrate whether the newly developed CADx system has a high-level diagnostic accuracy in predicting characterization of colorectal ulcerative diseases. It is a multi-center study with two phases. The first retrospective phase is the development and validation of a CADx system by feature extraction from endoscopic photos and videos. The second prospective phase is the evaluation and comparison of the diagnostic accuracy between the CADx system, expert endoscopists and junior endoscopists.

Conditions

Colorectal Ulcers; Computer-aided System

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy

  The diagnostic accuracy (area under receiver operating characteristic curves, AUROC) of newly developed CADx system in prediction of final histopathology.

  From 2023-07 to 2026-04

Secondary Outcomes (4)

• Sensitivity

  From 2023-07 to 2026-04

• Specificity

  From 2023-07 to 2026-04

• Positive predictive value

  From 2023-07 to 2026-04

• Negative predictive value

  From 2023-07 to 2026-04

Study Arms (1)

Test cohort

A set of test images and videos will be collected prospectively from other subjects, according to the eligibility criteria, followed by random allocation of computer-generated sequence.Two expert endoscopists (with more than 5 years of experience in colonoscopy and a total number of procedures more than 1,000) and two junior endoscopists (with less than 3 years of experience in colonoscopy and a total number of procedures less than 500), who are blinded to the final diagnostic result, will be invited to classify the test set images and videos according to the pre-defined subtypes. All endoscopists will assess the test set data independently in a real-time basis. On the other hand, the CADx system will scan the test set images and videos independently. The prediction of ulcer subtypes will be recorded. The formal diagnostic report after evaluation by independent pathologists and gastroenterologists will be regarded as the ground truth.

Diagnostic Test: Test images and videos

Interventions

Test images and videos DIAGNOSTIC_TEST

A set of test images and videos will be collected prospectively from other subjects, according to the eligibility criteria, followed by random allocation of computer-generated sequence.

Test cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

They underwent endoscopic examination and are found to have ulcerative lesions in the large intestine.

You may qualify if:

• They underwent endoscopic examination and are found to have ulcerative lesions in the large intestine;
• They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;
• They have the complete medical records and clear diagnosis.

You may not qualify if:

• )Poor quality endoscopic images and videos defined as:
• Incomplete visualization of the colorectal ulcer due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
• Artifacts due to mucus, air bubbles, stool, or blood. 2)Obscured view due to poor bowel preparation; 3)Incomplete medical record; 4)Prior history of intestinal resection, fistula, or anastomosis.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Longgang District People's Hospital: collaborator
• ZhuHai Hospital: collaborator
• Wuxi People's Hospital: collaborator

Central Study Contacts

Xiaobei Luo, PhD

CONTACT

17688881428; luoxiaobei63@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share