AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Colonoscopy after bowel cleansing: Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.

Intestinal biopsies: During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC

blood sampling: Blood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research.

Stool: The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.

Clinical follow-up: Patients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated.

Study summary

This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.

Eligibility

Primary outcome measure(s)

• Diagnostic performance of the new scoring system — 6 months
  To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity

Trial sites (11)

Other trials for the same condition