- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401004
Effect of Blink-Based Training on Cancer Detection in Colorectal Polyp Images by Medical Students/Non GI-trainees (Blink)
Assessment of Blink Impression for Cancer Detection in Colorectal Polyps Among Medical Students and Non-GI Trainees: A Pre-Post Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale:
Colorectal cancer (CRC) remains a leading cause of cancer-related mortality in Western countries, though it is largely preventable by detecting and removing precursor lesions such as colorectal polyps. While most polyps are small and benign, 1-2% are large (≥20 mm) non-pedunculated colorectal polyps (LNPCPs), which carry a markedly higher risk of invasive cancer (reported rates 6-15%, depending on morphology, histology, and location).
Accurate optical diagnosis of cancer in LNPCPs is critical for guiding treatment strategy-piecemeal endoscopic resection, en bloc resection, or surgery. However, endoscopists often underperform in identifying cancer within these lesions. Studies have reported correct cancer identification rates as low as 20-40%, even among trained endoscopists, contributing to unnecessary surgeries for benign polyps and missed diagnoses in malignant cases.
One contributing factor is the complexity of existing classification systems, which are rarely applied consistently in clinical practice. Simplified tools may improve accuracy and applicability.
The Blink framework, inspired by Malcolm Gladwell's concept of rapid, intuitive decision-making and aligned with Kahneman's System 1 thinking, condenses cancer recognition into six easily observed features of LNPCPs:
Fold deformation Extra redness Chicken skin mucosa Depression Spontaneous bleeding Ulceration
These Blink features can be recognized without advanced imaging and provide a structured, intuitive framework for rapid cancer detection. Previous research has shown that teaching these features improves endoscopists' diagnostic sensitivity. Building on this, the present study evaluates whether a brief Blink-based intervention can improve cancer detection among medical students and non-GI trainees with no prior training in polyp morphology.
Primary Objective:
To assess whether a short educational intervention (2-minute training video on Blink features) improves the sensitivity of medical students and non-GI trainees in detecting cancer in colorectal polyps using static images.
Secondary Objectives
- To evaluate changes in specificity, self-reported confidence, and interobserver agreement before and after the intervention.
- To identify which Blink features are associated with accurate cancer detection.
- To assess the relationship between the number of Blink features identified and diagnostic accuracy.
Study Design:
Design: Prospective interventional study with pre- and post-intervention assessments.
Setting: Online survey distributed to medical students and non-GI trainees affiliated with the Vrije Universiteit Brussel.
Intervention: 2-minute video training on the six Blink features, followed by re-assessment of images.
Target Population:
Medical students and non-GI trainees affiliated with the Vrije Universiteit Brussel without prior endoscopy experience.
Sample size: 50-100 participants (yielding 1,000-2,000 individual image evaluations).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels Capital
-
Jette, Brussels Capital, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Images of large non-pedunculated colorectal polyps (LNPCPs) obtained from patients who have provided informed consent for the anonymous use of polyp images during colonoscopy (EC-2024-200).
- Medical students and non-GI trainees who have provided written informed consent to participate in the study.
Exclusion Criteria:
- Participants (students or non-GI trainees) with prior experience in endoscopy or polyp detection, or those who do not provide informed consent.
- Images deemed to be of insufficient quality by the principal investigator.
- Patients who do not provide informed consent for image use and data collection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Arm: Blink Features Training
Medical students and non-GI trainees complete a baseline assessment of colorectal polyp images, receive a brief 2-minute educational video on Blink features, and then complete a post-intervention assessment.
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A brief (2-minute) educational video introducing six Blink features (fold deformation, extra redness, chicken skin mucosa, depression, spontaneous bleeding, ulceration) to improve recognition of colorectal cancer in large non-pedunculated colorectal polyps.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sensitivity for detection of colorectal cancer in polyp images
Time Frame: Immediately before and after the educational intervention (within one online survey session, approximately 15-20 minutes).
|
Sensitivity will be calculated as the proportion of correctly identified cancerous polyps out of all cancerous polyps presented.
Comparison will be made between pre-intervention and post-intervention assessments.
|
Immediately before and after the educational intervention (within one online survey session, approximately 15-20 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in specificity for cancer detection
Time Frame: Immediately before and after the educational intervention (single online session, ~15-20 minutes).
|
Specificity: proportion of cancerous polyps correctly identified as cancerous.
Compared pre- vs post-intervention using the same participant as their own control.
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Immediately before and after the educational intervention (single online session, ~15-20 minutes).
|
|
Change in self-reported diagnostic confidence
Time Frame: Immediately before and after the educational intervention (same session).
|
Mean confidence score per case (e.g., 1-5 Likert scale) averaged per participant, compared pre- vs post-intervention.
|
Immediately before and after the educational intervention (same session).
|
|
Change in interobserver agreement (Fleiss' kappa)
Time Frame: Immediately before and after the educational intervention (same session).
|
Agreement among participants on cancer vs non-cancer classification, computed as Fleiss' kappa and compared pre- vs post-intervention
|
Immediately before and after the educational intervention (same session).
|
|
Correlation between presence of individual Blink features and correct cancer classification
Time Frame: Baseline (pre-intervention) and immediately after the educational intervention (within the same online survey session, ~15-20 minutes).
|
For each endoscopic image, participants will indicate the presence or absence of predefined Blink features (fold deformation, extra redness, chicken skin mucosa, depression, spontaneous bleeding, ulceration). Each feature will be analyzed separately. The presence of each feature will be correlated with diagnostic accuracy, defined as the proportion (%) of correct classifications (cancer vs non-cancer) across participants, using histology as the reference standard. Measurement Tool: Online survey with image annotation for Blink features and classification task for cancer vs non-cancer. Unit of Measure: Correlation coefficient (r) between presence/absence of each Blink feature and diagnostic accuracy (%). |
Baseline (pre-intervention) and immediately after the educational intervention (within the same online survey session, ~15-20 minutes).
|
|
Correlation between number of Blink features identified and diagnostic accuracy
Time Frame: Immediately after the educational intervention (within the same online survey session, ~15-20 minutes).
|
For each image, participants will indicate the presence or absence of predefined Blink features (fold deformation, extra redness, chicken skin mucosa, depression, spontaneous bleeding, ulceration). The per-image/per-participant count of features identified will then be correlated with diagnostic accuracy (% of correct cancer vs non-cancer classifications). Measurement Tool: Online survey with image annotation for Blink features and classification task for cancer vs non-cancer (histology as reference standard). Unit of Measure: Correlation coefficient (r) between number of Blink features identified and diagnostic accuracy (%). |
Immediately after the educational intervention (within the same online survey session, ~15-20 minutes).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25311_Blink (Other Identifier: UZ Brussel)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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