Colorectal PolypNCT05699954
Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps
An observational study of Colorectal Polyp and Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. 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, Colono
- What is being tested?
- Presence of Blink impression features for cancer in colorectal polyps
- How many people
- 191 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: * Endoscopists of varying experience (trainees, consultants, expert endoscopists, interventional endoscopists. * Patients with LNPCPs
Who may be able to join
- Endoscopists of varying abilities and grades (participant endoscopist) that consents electronically
- Patients with LNPCPs who signed the ICF of UZ Ghent Hospital for the anonymous use images of their polyp taken during colonoscopy
Who cannot join
- Endoscopist does not consent to inclusion (participant endoscopist)
- Image of inadequate quality as per opinion of the principal investigator
- Patient does not consent to data collection for the study (participant patient)
Trial locations and contacts
1 site in 1 country.
About this study
Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. If submucosal invasive cancer (SMI) is suspected, careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy.
Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcomes (e.g. piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease).
Read more
Studies from the field of psychology show that humans are often capable of making correct decision based on their Blink (first) impression. It is also suggested that this Blink impression is based on experience and training. This might suggest that experienced or specialist endoscopist are better at diagnosing SMI within colorectal polyp at Blink impression.
The investigators hypothesize that by training the Blink impression, endoscopist of varying experience are able to detect cancer within LNPCPs. This can be proven by assessing the Blink impression of endoscopist of varying experience regarding the presence of SMI within LNPCPs.
Increasing the accuracy of the determination of SMI within colon polyps would directly translate into improvements in patient care and outcome.
For example, if SMI is present and is not suspected, patients may undergo unnecessary endoscopic procedures for an LNPCP which will eventually require surgery anyway (inconvenience, delayed correct treatment). If the incorrect technique is performed in the context of superficial SMI, adequate assessment of complete excision or extent and type of SMI may not be possible and a patient who would otherwise have been cured may require surgery anyway (under-treatment, below standard of care outcome, delay to treatment). Conversely, if SMI is suspected in its absence patients may undergo unnecessary surgery, increased healthcare spends and mortality (over-treatment, unnecessary risk). If the presence of SMI could be accurately determined in real-time using endoscopic imaging, delays to treatment, over-treatment and the associated morbidity for patients could be avoided.
- Conditions
- Colorectal Polyp, Colorectal Cancer, Colono
- Being tested
- Presence of Blink impression features for cancer in colorectal polyps
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of Blink impression features for cancer in colorectal polypsDiagnostic test
- 20 LNPCPs will be collected from the UZ Ghent database (all LNPCPs, ICF present).
- A survey will be made where participant endoscopist will be informed about the study. They will here be asked for electronic consent.
- The survey asks for demographics of the participant endosopists (experience, country where they work).
- The last part of the survey is where the 20 images of the LNPCPs are shown. After evere image 4 questions are asked. Is this a colorectal polyp? (Yes/No)
- Is your Blink (first) Impression that this polyp contains cancer? (Yes/No)
- If "yes", why do you think that? (Free comment box)
- What treatment would you recommend for this polyp? (piecemeal endoscopic mucosal resection/endoscopic submucosal disection/surgery)
- Study will be closed after 2 weeks.
- Data analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs, using the Blink (first) impression when analysing images of LNPCPs.
Measured: Through study completion, Study is open for 2 weeks
Secondary outcomes (1)
Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.
Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.
Measured: Through study completion, Study is open for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699954
- Sponsor's protocol ID
- ONZ-2022-0488
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps
- ClinicalTrials.gov ID
- NCT05699954
- Acronym / sponsor ID
- ONZ-2022-0488
- Conditions
- Colorectal Polyp, Colorectal Cancer, Colono
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 26 Jan 2023 (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 (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. If submucosal invasive cancer (SMI) is suspected, careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy.
Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcomes (e.g. piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease).
Studies from the field of psychology show that humans are often capable of making correct decision based on their Blink (first) impression. It is also suggested that this Blink impression is based on experience and training. This might suggest that experienced or specialist endoscopist are better at diagnosing SMI within colorectal polyp at Blink impression.
The investigators hypothesize that by training the Blink impression, endoscopist of varying experience are able to detect cancer within LNPCPs. This can be proven by assessing the Blink impression of endoscopist of varying experience regarding the presence of SMI within LNPCPs.
Increasing the accuracy of the determination of SMI within colon polyps would directly translate into improvements in patient care and outcome.
For example, if SMI is present and is not suspected, patients may undergo unnecessary endoscopic procedures for an LNPCP which will eventually require surgery anyway (inconvenience, delayed correct treatment). If the incorrect technique is performed in the context of superficial SMI, adequate assessment of complete excision or extent and type of SMI may not be possible and a patient who would otherwise have been cured may require surgery anyway (under-treatment, below standard of care outcome, delay to treatment). Conversely, if SMI is suspected in its absence patients may undergo unnecessary surgery, increased healthcare spends and mortality (over-treatment, unnecessary risk). If the presence of SMI could be accurately determined in real-time using endoscopic imaging, delays to treatment, over-treatment and the associated morbidity for patients could be avoided.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Endoscopists of varying experience (trainees, consultants, expert endoscopists, interventional endoscopists. * Patients with LNPCPs
Key inclusion criteria (2 listed)
- Endoscopists of varying abilities and grades (participant endoscopist) that consents electronically
- Patients with LNPCPs who signed the ICF of UZ Ghent Hospital for the anonymous use images of their polyp taken during colonoscopy
Key exclusion criteria (3 listed)
- Endoscopist does not consent to inclusion (participant endoscopist)
- Image of inadequate quality as per opinion of the principal investigator
- Patient does not consent to data collection for the study (participant patient)
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 |
|---|---|---|
| Presence of Blink impression features for cancer in colorectal polyps1. 20 LNPCPs will be collected from the UZ Ghent database (all LNPCPs, ICF present). 2. A survey will be made where participant endoscopist will be informed about the study. They will here be asked for electronic consent. 3. The survey asks for demographics of the participant endosopists (experience, country where they work). 4. The last part of the survey is where the 20 images of the LNPCPs are shown. After evere image 4 questions are asked. Is this a colorectal polyp? (Yes/No) * Is your Blink (first) Impression that this polyp contains cancer? (Yes/No) * If "yes", why do you think that? (Free comment box) * What treatment would you recommend for this polyp? (piecemeal endoscopic mucosal resection/endoscopic submucosal disection/surgery) 5. Study will be closed after 2 weeks. 6. Data analysis | Diagnostic test | – |
Primary outcome
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.
Time frame: Through study completion, Study is open for 2 weeks
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs, using the Blink (first) impression when analysing images of LNPCPs.
1 secondary outcome
Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.
Time frame: Through study completion, Study is open for 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs. (time frame: Through study completion, Study is open for 2 weeks). 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 24 Apr 2023.