A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia (CADx)

The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: CADx

Detailed Description

Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited.

Recently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings.

A novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.

• Study Type: Observational
• Enrollment (Estimated): 510

Contacts and Locations

• Study Contact: Name: Felix Sia; Phone Number: 26370428; Email: felixsia@cuhk.edu.hk
• Study Contact Backup: Name: Thomas Lam; Phone Number: 26370428; Email: thomaslam@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with colorectal neoplasia

Description

Inclusion Criteria:

1. They have received colonoscopy for screening, surveillance or symptom investigation;
2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;
3. They have histologically proven colorectal neoplasia.
4. Written consent obtained

Exclusion Criteria:

1. Poor quality endoscopic images and videos defined as:

   1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
   2. Artifacts due to mucus, air bubbles, stool, or blood.
2. Active gastrointestinal bleeding;
3. Fulminant colitis;
4. Obscured view due to poor bowel preparation;
5. Artificial staining of lesion due to chromoendoscopy.
6. Unable to obtain informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CADx; Histopathology prediction by CADx device	Device: CADx; A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.
Endoscopist; Real-time histopathology prediction by expert and non-expert endoscopists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	area under receiver operating characteristic curves, AUROC in prediction of final histopathology	During the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity	During the colonoscopy
Specificity	Specificity	During the colonoscopy
Positive predictive value	Positive predictive value	During the colonoscopy
Negative predictive value	Negative predictive value	During the colonoscopy
Diagnostic time	Diagnostic time	During the colonoscopy

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: University College, London; Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2022.160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No