Colorectal PolypSCARNCT06193356
Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable
A study testing Learning tool in people with Colorectal Polyp and Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Colorectal Cancer
- What is being tested?
- Learning tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Nov 2024to 1 Jan 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Endoscopists of any experience level
Who cannot join
- non consenting adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention
Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology. In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA.
After consent is given, the participant will open the online survey and fill this in.
Read more
First the participant will be asked to create a pseudonym (name+year of birth) and fill in their demographical information (Grade, years in current role, colonoscopy experience, experience of colonic tissue resection, country of employment
The first 15 pictures will be shown prior to a learning intervention. For each picture the same questions will be asked:
- Is this an endoscopic resection scar?
- Based on this image does the scar demonstrate evidence of residual or recurrent adenoma (RRA)?
- What is your level of confidence?
- If the scar shows RRA, how would you treat it? (skip if you feel no RRA).
- If the scar does not show RRA do you feel there is another diagnosis? After the first 15 pictures a video-based learning tool will be shown on detection of RRA.
After the learning tool 15 different pictures will be shown, the same questions will be asked. All responses will be collected by the investigators. Statistical analysis will be performed using visual studio code (Microsoft, Redmond, USA) Images will be selected from the 'Australian Colonic LSL Endoscopic Resection Study' (ACE) database, which is an international multicentre registry of images and videos for retrospective analysis of colonic lesions. Images, videos, procedural information, and histopathological data are stored on a secure online web portal after written informed consent of every participating patient.
- Conditions
- Colorectal Polyp, Colorectal Cancer
- Being tested
- Learning tool
- Keywords
- endoscopy, advanced imaging, post-colonoscopy colorectal cancer, Colorectal polypectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning toolOther
Video based learning tool about detection of endoscopic resection scars and recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Pre learning tool | No intervention | Assessment of endoscopic images prior to a learning tool about scars and recurrence |
| post learning tool | Experimental | Assessment of endoscopic images after a learning tool about scars and recurrence Receives: Other: Learning tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of detecting a recurrence at an endoscopic resection scar.
Performance of detecting a recurrence at an endoscopic resection scar.
Measured: 2 years
Secondary outcomes (3)
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar
Measured: 2 year
Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level
Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level
Measured: 2 year
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start11 Nov 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A survey containing 15 High Definition - White Light (HD-WL) and Narrow Band Imaging (NBI) images, a learning intervention on detection of RRA (LT), then another set of 15 images was circulated to a mailing list of the GIEQs (Gastrointestinal Endoscopy Quality and Safety) foundation. Each image contained the same questions: Is this a resection scar? Is there RRA? What is your level of confidence? Information on the participant was obtained: number of EMRs performed, grade (consultant vs trainee) and years of experience. Comparisons were made to expert opinion derived at a consensus meeting of the senior authors regarding the appearances of the scars using the approach set out in Desomer et al. 2017.
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Tate, PhD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193356
- Sponsor's protocol ID
- ONZ-2024-0133 - ID16649
- Acronym
- SCAR
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention
- ClinicalTrials.gov ID
- NCT06193356
- Acronym / sponsor ID
- SCAR / ONZ-2024-0133 - ID16649
- Conditions
- Colorectal Polyp, Colorectal Cancer
- Keywords
- endoscopy, advanced imaging, post-colonoscopy colorectal cancer, Colorectal polypectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Jan 2024 (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.
Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology. In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA.
After consent is given, the participant will open the online survey and fill this in.
First the participant will be asked to create a pseudonym (name+year of birth) and fill in their demographical information (Grade, years in current role, colonoscopy experience, experience of colonic tissue resection, country of employment
The first 15 pictures will be shown prior to a learning intervention. For each picture the same questions will be asked:
- Is this an endoscopic resection scar?
- Based on this image does the scar demonstrate evidence of residual or recurrent adenoma (RRA)?
- What is your level of confidence?
- If the scar shows RRA, how would you treat it? (skip if you feel no RRA).
- If the scar does not show RRA do you feel there is another diagnosis? After the first 15 pictures a video-based learning tool will be shown on detection of RRA.
After the learning tool 15 different pictures will be shown, the same questions will be asked. All responses will be collected by the investigators. Statistical analysis will be performed using visual studio code (Microsoft, Redmond, USA) Images will be selected from the 'Australian Colonic LSL Endoscopic Resection Study' (ACE) database, which is an international multicentre registry of images and videos for retrospective analysis of colonic lesions. Images, videos, procedural information, and histopathological data are stored on a secure online web portal after written informed consent of every participating patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A survey containing 15 High Definition - White Light (HD-WL) and Narrow Band Imaging (NBI) images, a learning intervention on detection of RRA (LT), then another set of 15 images was circulated to a mailing list of the GIEQs (Gastrointestinal Endoscopy Quality and Safety) foundation. Each image contained the same questions: Is this a resection scar? Is there RRA? What is your level of confidence? Information on the participant was obtained: number of EMRs performed, grade (consultant vs trainee) and years of experience. Comparisons were made to expert opinion derived at a consensus meeting of the senior authors regarding the appearances of the scars using the approach set out in Desomer et al. 2017.
| Arm | Type | Receives |
|---|---|---|
| Pre learning tool | No intervention | –Assessment of endoscopic images prior to a learning tool about scars and recurrence |
| post learning tool | Experimental | Other: Learning toolAssessment of endoscopic images after a learning tool about scars and recurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists of any experience level
Key exclusion criteria (1 listed)
- non consenting adults
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 |
|---|---|---|
| Learning toolVideo based learning tool about detection of endoscopic resection scars and recurrence. | Other | post learning tool |
Primary outcome
Performance of detecting a recurrence at an endoscopic resection scar.
Time frame: 2 years
Performance of detecting a recurrence at an endoscopic resection scar.
3 secondary outcomes
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar
Time frame: 2 year
Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level
Time frame: 2 year
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level
Time frame: 2 year
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 25 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers
Related trials for Colorectal Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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.
David J Tate, PhD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning tool in people with Colorectal Polyp and Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 David J trate, PhD (09 332 21 11 ext. +32, David.tate@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of detecting a recurrence at an endoscopic resection scar. (time frame: 2 years). 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 25 Nov 2025.