Development of a New Simplified Tool to Predict LNPCPs Histology and Assess the Risk of Submucosal Invasive Cancer. The Colorectal Regular-Irregular Score

Sponsor
University Hospital, Ghent
Study ID
NCT07584486
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Learning tool (CRIS/JNET) — OTHER
    Participants will follow a 5-minute learning video (intervention) on CRIS and later for JNET.
  • Learning tool (JNET/CRIS) — OTHER
    Participants will follow a 5-minute learning video (intervention) on JNET and later for CRIS.

Study Details

Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer related death. It can be prevented by endoscopic detection and complete resection of colorectal polyps. The JNET (Japanese NBI Expert Team) classification is clinically useful to predict the histology of large non-pedunculated colorectal polyps (LNPCPs) using narrow-band imaging at endoscopy. Japanese experts can reliably predict histology including the presence and depth of submucosal invasive cancer (SMI) using JNET with accuracy \>87%. On the other hand, the International Evaluation of Endoscopy classification-JNET (IEE-JNET) group demonstrated that ESGE and JGES endoscopists had sufficient accuracy for JNET 1 (93.0%) but insufficient accuracy for JNET 2A/B and 3 (respectively 62.1%, 55.1% and 85.1%). Reliably distinguishing between JNET 2A, 2B and 3 has a profound clinical relevance, since JNET 2A lesions can safely be resected using pEMR whereas JNET 2B lesions should be resected en-bloc (EMR or ESD) due to the increased risk of cancer and JNET 3 lesions are preferably treated with surgery due to the high risk of deeply invasive carcinoma and the necessity of lymph node resection. This study aims to validate a new simplified score, the Colorectal Regular-Irregular Score (CRIS) to fulfill the urgent need for a more effective and easier to use tool to predict LNPCPs histology. CRIS is a simplification of the JNET score which is mainly used by Japanese endoscopists or experts, recent evidence suggests its accuracy when used in everyday endoscopy in the Western world is insufficient. The investigators aim to compare JNET with CRIS for LNPCPs histology prediction amongst Western endoscopists using both original JNET interpretation and a clinically relevant approach. The study consists of three work packages (WPs): Work package one involves an expert online study where twelve expert endoscopists will evaluate 32 high-quality images of colorectal polyps using both JNET and CRIS classifications. Work package two involves an image/video-based online study where non-expert participants will be randomly assigned to rate images and videos using either JNET or CRIS, with performance re-evaluated after three months. Work package three involves a clinical study in a live endoscopy environment where non-expert endoscopists will participate in a randomized controlled trial assessing 10 colorectal polyps using either JNET or CRIS.

Key Dates

First listed
May 13, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
764 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: JNET Classification Training (Active Comparator)
  • Experimental: CRIS Classification Training (Experimental)

Primary Outcome Measure

Diagnostic Accuracy of CRIS Classification for Submucosal Invasive Carcinoma (Sensitivity, Specificity, and Overall Accuracy) [ Time Frame: Immediately after 5-minute training and rating of 32 images (approximately 1 hour per participant) ]

Central Contacts

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies