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

Recruiting now

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT06709209

Run by

University College Cork

People needed

300

Starts

2024-11-04

Expected to finish

2027-09-30

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Naples — Naples, Italy (enrolling)
• University College Cork — Cork, Co Cork, Ireland (enrolling)
• 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 Pavia — Pavia, Italy
• Showa University — Tokyo, Japan
• University of Leuven — Leuven, Belgium
• Changi General Hospital — Singapore, Singapore
• Klinikum Luneburg — Lüneburg, Germany

Full record on ClinicalTrials.gov

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