UCRecruiting
AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
Observational · No treatment assigned · 11 sites · University College Cork
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2024-11-04.
- Main results expected around 2026-09-30 (estimate from the record).
- 11 study sites listed (2 marked recruiting) in Belgium, Germany, Ireland, Italy and Japan and 1 more countries.
Main thing being measured
- Diagnostic performance of the new scoring system (6 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | University College Cork |
| Collaborators | Olympus |
| Enrollment | 300 (estimated) |
| Start date | 2024-11-04 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2024-11-29 |
| Last updated | 2024-12-03 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06709209 |
Interventions
- Colonoscopy after bowel cleansing (Procedure)
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI. - Intestinal biopsies (Procedure)
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)
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.
Full eligibility criteria (from the record)
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
Locations (11)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Leuven | Leuven | Belgium | Not yet recruiting |
| Klinikum Luneburg | Lüneburg | Germany | Not yet recruiting |
| University College Cork | Cork, Co Cork | Ireland | Recruiting |
| University of Bari | Bari | Italy | Not yet recruiting |
| Istituto Clinico Humanitas | Milan | Italy | Not yet recruiting |
| University Vita-Salute San Raffaele | Milan | Italy | Not yet recruiting |
| University of Naples | Naples | Italy | Recruiting |
| University of Pavia | Pavia | Italy | Not yet recruiting |
| Ospedale S. Maria del Prato | Feltre, Belluno | Italy | Not yet recruiting |
| Showa University | Tokyo | Japan | Not yet recruiting |
| Changi General Hospital | Singapore | Singapore | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.