AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
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
University College Cork
300 participants
Nov 4, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- Adult patients aged 18 to 75 years old
- Established diagnosis of UC (for at least six months in duration), independently from their active treatment
- Undergoing endoscopy for disease activity assessment or cancer surveillance.
Exclusion Criteria6
- Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
- Poor bowel preparation (defined as total BBPS \<6 or BBPS \<2 in observed segment for sigmoidoscopy)
- Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
- Pregnant and breast-feeding subjects
- Inability to provide informed consent
- If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study
Interventions
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.
During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC
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.
The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06709209