RecruitingNCT06709209

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


Sponsor

University College Cork

Enrollment

300 participants

Start Date

Nov 4, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an AI-powered scoring system applied to narrow-band imaging (a special colonoscopy technique that highlights blood vessels in the bowel lining) can accurately assess disease severity and predict outcomes in people with ulcerative colitis. **You may be eligible if...** - You are between 18 and 75 years old - You have had a confirmed diagnosis of ulcerative colitis for at least 6 months - You are undergoing a colonoscopy to assess disease activity or for cancer surveillance **You may NOT be eligible if...** - You have conditions that make colonoscopy or biopsies unsafe (e.g., toxic megacolon, severe blood clotting problems) - Your bowel preparation before the procedure was inadequate - You are pregnant or breastfeeding - You have been in another experimental study within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy after bowel cleansing

Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.

PROCEDUREIntestinal biopsies

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

DIAGNOSTIC_TESTblood 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.

DIAGNOSTIC_TESTStool

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

OTHERClinical 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

View Full Details on ClinicalTrials.gov

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NCT06709209


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