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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • UZ Gent

    Ghent, 9000

Other trials in Belgium

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.

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

    1. 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)
    1. Study will be closed after 2 weeks.
    2. Data analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted26 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Resources

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)
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

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.

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