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

NCT05414383 | Not Yet Recruiting DMC

• 1 other identifier: 2022.160
• Study Type: observational
• Target: 510
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  area under receiver operating characteristic curves, AUROC in prediction of final histopathology

  During the colonoscopy

Secondary Outcomes (5)

• Sensitivity

  During the colonoscopy

• Specificity

  During the colonoscopy

• Positive predictive value

  During the colonoscopy

• Negative predictive value

  During the colonoscopy

• Diagnostic time

  During the colonoscopy

Study Arms (2)

CADx

Histopathology prediction by CADx device

Device: CADx

Endoscopist

Real-time histopathology prediction by expert and non-expert endoscopists

Interventions

CADx DEVICE

A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.

CADx

Eligibility Criteria

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

Study Population

Patient with colorectal neoplasia

You may qualify if:

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

You may not qualify if:

• Poor quality endoscopic images and videos defined as:
• Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
• Artifacts due to mucus, air bubbles, stool, or blood.
• Active gastrointestinal bleeding;
• Fulminant colitis;
• Obscured view due to poor bowel preparation;
• Artificial staining of lesion due to chromoendoscopy.
• Unable to obtain informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Nanfang Hospital, Southern Medical University: collaborator
• University College, London: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Thomas Lam

CONTACT

26370428; thomaslam@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share