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AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
Sponsor: University College Cork
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.
Official title: A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-11-04
Completion Date
2027-09-30
Last Updated
2024-12-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (11)
University of Leuven
Leuven, Belgium
Klinikum Luneburg
Lüneburg, Germany
University College Cork
Cork, Co Cork, Ireland
Ospedale S. Maria del Prato
Feltre, Belluno, Italy
University of Bari
Bari, Italy
Istituto Clinico Humanitas
Milan, Italy
University Vita-Salute San Raffaele
Milan, Italy
University of Naples
Naples, Italy
University of Pavia
Pavia, Italy
Showa University
Tokyo, Japan
Changi General Hospital
Singapore, Singapore