Colorectal NeoplasmsCADxNCT05414383
A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
An observational study of Colorectal Neoplasms, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- CADx
- Type of treatment
- Medical device
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with colorectal neoplasia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- CADx
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADxDevice
A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| CADx | Histopathology prediction by CADx device Receives: Device: CADx | |
| Endoscopist | Real-time histopathology prediction by expert and non-expert endoscopists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
area under receiver operating characteristic curves, AUROC in prediction of final histopathology
Measured: During the colonoscopy
Secondary outcomes (5)
Sensitivity
Sensitivity
Measured: During the colonoscopy
Specificity
Specificity
Measured: During the colonoscopy
Positive predictive value
Positive predictive value
Measured: During the colonoscopy
Negative predictive value
Negative predictive value
Measured: During the colonoscopy
Diagnostic time
Diagnostic time
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study startDec 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, University College, London
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414383
- Sponsor's protocol ID
- 2022.160
- Acronym
- CADx
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT05414383
- Acronym / sponsor ID
- CADx / 2022.160
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, University College, London
- Study start
- Dec 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADx | – | Device: CADxHistopathology prediction by CADx device |
| Endoscopist | – | –Real-time histopathology prediction by expert and non-expert endoscopists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with colorectal neoplasia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Poor quality endoscopic images and videos defined as:
- Active gastrointestinal bleeding;
- Fulminant colitis;
- Obscured view due to poor bowel preparation;
- Artificial staining of lesion due to chromoendoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CADxA novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy. | Device | CADx |
Primary outcome
Diagnostic accuracy
Time frame: During the colonoscopy
area under receiver operating characteristic curves, AUROC in prediction of final histopathology
5 secondary outcomes
Sensitivity
Time frame: During the colonoscopy
Specificity
Time frame: During the colonoscopy
Positive predictive value
Time frame: During the colonoscopy
Negative predictive value
Time frame: During the colonoscopy
Diagnostic time
Time frame: During the colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Sia (26370428, felixsia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: During the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.