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

7 maggio 2026 aggiornato da: University Hospital, Ghent

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

764

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Belgio
      • Ghent, Belgio, 9000
        • UZ Gent

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Consenting Endoscopists of varying abilities and grades (endoscopist)
  • Endoscopists who did not previously encounter the score (endoscopist)
  • LNPCPs detected or referred for resection (patient)

Exclusion Criteria:

  • Endoscopist does not consent to inclusion (endoscopist)
  • Video of inadequate quality as per opinion of the principal investigator
  • Endoscopist does not undergo learning intervention (endoscopist)
  • Patient does not consent to data collection for the study (patient)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: JNET Classification Training (Active Comparator)
Altro: Learning tool (JNET/CRIS)
Participants will follow a 5-minute learning video (intervention) on JNET and later for CRIS.
Sperimentale: CRIS Classification Training (Experimental)
Altro: Learning tool (CRIS/JNET)
Participants will follow a 5-minute learning video (intervention) on CRIS and later for JNET.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Accuracy of CRIS Classification for Submucosal Invasive Carcinoma (Sensitivity, Specificity, and Overall Accuracy)
Lasso di tempo: Immediately after 5-minute training and rating of 32 images (approximately 1 hour per participant)
Sensitivity, specificity, and overall diagnostic accuracy of the CRIS classification for predicting submucosal invasive carcinoma compared with histopathological evaluation (reference standard). Accuracy is calculated as the proportion of correct classifications (true positives + true negatives) divided by total assessments. Results will be reported with 95% confidence intervals.
Immediately after 5-minute training and rating of 32 images (approximately 1 hour per participant)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Accuracy of CRIS Versus JNET Among Expert Endoscopists (Sensitivity, Specificity, Overall Accuracy)
Lasso di tempo: At completion of expert image rating (approximately 30 minutes per expert)
Comparison of sensitivity, specificity, and overall diagnostic accuracy between CRIS and JNET classifications among 12 expert endoscopists rating 32 polyp images. Accuracy calculated as proportion of correct histopathology predictions. Results reported with 95% confidence intervals.
At completion of expert image rating (approximately 30 minutes per expert)
Diagnostic Accuracy of CRIS Versus JNET Across All Participant Categories (Sensitivity, Specificity, Overall Accuracy)
Lasso di tempo: Through study completion, an average of 3 years
Comparison of sensitivity, specificity, and overall diagnostic accuracy between CRIS and JNET classifications across all participant categories (experts, consultants, trainees, medical students, endoscopy nurses). Accuracy calculated as proportion of correct histopathology predictions using generalized linear mixed model analysis.
Through study completion, an average of 3 years
Change in Diagnostic Accuracy From Baseline to 3-Month Follow-up for CRIS Versus JNET (Sensitivity, Specificity, Overall Accuracy)
Lasso di tempo: 3 months after initial assessment
Change in sensitivity, specificity, and overall diagnostic accuracy from immediate post-training assessment to 3-month delayed assessment for participants using CRIS versus JNET. Reported as absolute change in accuracy with 95% confidence intervals. A smaller decrease indicates better retention of classification skills.
3 months after initial assessment
Inter-observer Agreement for Polyp Classification Using CRIS Versus JNET (Fleiss' Kappa Coefficient)
Lasso di tempo: At completion of baseline image assessment (approximately 1 hour per participant)
Inter-observer agreement among non-expert endoscopists for polyp classification using CRIS versus JNET, measured using Fleiss' kappa coefficient. Values interpreted as: <0.20 poor, 0.21-0.40 fair, 0.41-0.60 moderate, 0.61-0.80 substantial, 0.81-1.00 almost perfect agreement.
At completion of baseline image assessment (approximately 1 hour per participant)
Correlation Between Proposed Endoscopic Treatment and CRIS/JNET Classification (Percentage Agreement)
Lasso di tempo: At completion of baseline image/video assessment (approximately 1 hour per participant)
Percentage of cases where the proposed endoscopic treatment (piecemeal EMR, en-bloc EMR/ESD, or surgical referral) aligns with the guideline-recommended treatment based on CRIS or JNET classification. Higher agreement indicates the classification effectively guides treatment selection.
At completion of baseline image/video assessment (approximately 1 hour per participant)
Change in CRIS/JNET Diagnostic Accuracy Following 5-Minute Structured Learning Intervention (Pre-Post Difference in Overall Accuracy)
Lasso di tempo: Immediately before and immediately after 5-minute learning video intervention (within a single 1-hour session)
Change in overall diagnostic accuracy from pre-intervention baseline to immediately post-intervention for CRIS and JNET classifications. Reported as absolute difference in accuracy percentage with 95% confidence intervals. The CRIS/JNET classification uses a scale where accuracy ranges from 0% (no correct classifications) to 100% (all classifications correct), with higher scores indicating better diagnostic performance.
Immediately before and immediately after 5-minute learning video intervention (within a single 1-hour session)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Ghent

Investigatori

  • Investigatore principale: David Tate, University Hospital, Ghent

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

14 agosto 2025

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ONZ-2024-0023

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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