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

Recruiting · NCT06709209 · Observational (researchers observe without assigning treatment) · Lead sponsor: University College Cork

View the official record on ClinicalTrials.gov →

Ulcerative colitis

Interventions studied

Clinical follow-upColonoscopy after bowel cleansingIntestinal biopsiesStoolblood sampling

What this trial is about

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.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

Inclusion criteria

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 criteria

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

11 locations listed.

University of Bari - Bari, Italy
University of Leuven - Leuven, Belgium
Klinikum Luneburg - Lüneburg, Germany
Istituto Clinico Humanitas - Milan, Italy
University Vita-Salute San Raffaele - Milan, Italy
University of Naples - Naples, Italy
University of Pavia - Pavia, Italy
Changi General Hospital - Singapore, Singapore
Showa University - Tokyo, Japan
Ospedale S. Maria del Prato - Feltre, Belluno, Italy
University College Cork - Cork, Co Cork, Ireland

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →