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

ConditionUlcerative Colitis (UC)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorUniversity College Cork

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Males and females between 18 and 75 years old with an established diagnosis of UC, who have undergone colonoscopy for disease assessment and surveillance will be consecutively recruited after obtaining written consent. The sample size in 300.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Colonoscopy after bowel cleansing
Procedure/Surgery
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.
Intestinal biopsies
Procedure/Surgery
During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC
blood sampling
Diagnostic test
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
Diagnostic test
The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.
Clinical follow-up
Other intervention
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.

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Ulcerative Colitis patients5 interventions

Trial outcomes

Primary outcomes

Diagnostic performance of the new scoring system

To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity

Time frame

6 months

Secondary outcomes

Correlation with existing score

To evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes

Time frame

2 years

AI development

Develop and adapt existing AI algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes in UC

Time frame

2 years