NCT06709209 AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
| NCT ID | NCT06709209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Cork |
| Condition | Ulcerative Colitis (UC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-11-04 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Marietta Iacucci, MD
PRINCIPAL INVESTIGATOR
University College Cork
Frequently Asked Questions
Who can join the NCT06709209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06709209 currently recruiting?
Yes, NCT06709209 is actively recruiting participants. Contact the research team at moriordan@ucc.ie for enrollment information.
Where is the NCT06709209 trial being conducted?
This trial is being conducted at Leuven, Belgium, Lüneburg, Germany, Cork, Ireland, Feltre, Italy and 7 additional locations.
Who is sponsoring the NCT06709209 clinical trial?
NCT06709209 is sponsored by University College Cork. The principal investigator is Marietta Iacucci, MD at University College Cork. The trial plans to enroll 300 participants.
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