NCT06505304 AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
| NCT ID | NCT06505304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Cork |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-10-31 |
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 225 participants in total. It began in 2024-05-01 with a primary completion date of 2025-10-31.
⚠ 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 is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.
Eligibility Criteria
Inclusion Criteria: * Patients aged between 18 years and 75 years. * Established diagnosis of CD at least six months prior to study. * Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned. Exclusion Criteria: * Inability to provide consent. * Presence of serious co-morbidities (clinical contraindication). * Presence of ostomy. * Pregnancy or breastfeeding. * Contraindication for colonoscopy or biopsies. * Boston Bowel Preparation Scale Score \<2 in the rectum plus left-sided colon. Exclusion criteria for pCLE only: * Allergy to nuts or shellfish. * Severe or uncontrolled asthma. * Use of beta blockers. * Previous history of reaction to fluorescein. Patients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.
Contact & Investigator
Marietta Iacucci, Professor
STUDY CHAIR
APC Microbiome Ireland, University College Cork
Frequently Asked Questions
Who can join the NCT06505304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505304 currently recruiting?
Yes, NCT06505304 is actively recruiting participants. Contact the research team at moriordan@ucc.ie for enrollment information.
Where is the NCT06505304 trial being conducted?
This trial is being conducted at Leuven, Belgium, Calgary, Canada, Erlangen, Germany, Cork, Ireland and 11 additional locations.
Who is sponsoring the NCT06505304 clinical trial?
NCT06505304 is sponsored by University College Cork. The principal investigator is Marietta Iacucci, Professor at APC Microbiome Ireland, University College Cork. The trial plans to enroll 225 participants.