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NCT Number: NCT05414383

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: During the colonoscopy

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

Secondary outcomes

  1. Sensitivity

    Time frame: During the colonoscopy

    Sensitivity

  2. Specificity

    Time frame: During the colonoscopy

    Specificity

  3. Positive predictive value

    Time frame: During the colonoscopy

    Positive predictive value

  4. Negative predictive value

    Time frame: During the colonoscopy

    Negative predictive value

  5. Diagnostic time

    Time frame: During the colonoscopy

    Diagnostic time

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Nanfang Hospital, Southern Medical University
  • University College, London

Registry information

Acronym: CADx

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2022
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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