AI technology to predict recurrence in Crohn's disease after surgery
Endoscopic Multimodal Assessment Using Advanced Imaging Integrated AI to Predict Recurrence in pOSt-oPerativE CRohn's Disease - PROSPER Study
This study is testing a new AI tool that uses advanced imaging to help doctors predict if Crohn's disease will come back after surgery, so they can identify patients who might need early treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Locations | 15 sites (Leuven and 14 other locations) |
| Trial ID | NCT06505304 on ClinicalTrials.gov |
What this trial studies
This multicentre international observational study aims to develop a novel endoscopic assessment system that utilizes advanced imaging techniques and artificial intelligence to predict post-operative recurrence of Crohn's disease. By integrating enhanced imaging methods like virtual chromoendoscopy and confocal laser endomicroscopy with immune marker profiling and clinical data, the study seeks to identify high-risk patients who may benefit from early intervention. The goal is to improve risk stratification and reduce variability in assessments, ultimately enhancing patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of Crohn's disease who have undergone intestinal resection within the last three months or have surgery planned.
Not a fit: Patients with serious co-morbidities, those who cannot provide consent, or individuals with contraindications for colonoscopy or biopsies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more effective treatments for patients at high risk of Crohn's disease recurrence after surgery.
How similar studies have performed: While the use of AI in medical imaging is a growing field, this specific multidimensional approach to predicting post-operative recurrence in Crohn's disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven and 14 other locations
- University of Leuven — Leuven, Belgium (Active_not_recruiting)
- University of Calgary — Calgary, Canada (Recruiting)
- University Hospital Erlangen — Erlangen, Germany (Active_not_recruiting)
- Cork University Hospital — Cork, Ireland (Active_not_recruiting)
- Mercy University Hospital — Cork, Ireland (Active_not_recruiting)
- University College Dublin — Dublin, Ireland (Recruiting)
- University College Hospitals Galway — Galway, Ireland (Active_not_recruiting)
- Rabin Medical Centre — Tel Aviv, Israel (Recruiting)
- Istituto Clinico Humanitas — Rozzano, Milan, Italy (Active_not_recruiting)
- ASST Spedali Civili — Brescia, Italy (Active_not_recruiting)
- ASST Fatebenefratelli Sacco — Milan, Italy (Recruiting)
- IRCCS Cà Granda Ospedale Maggiore — Milan, Italy (Recruiting)
- University Vita-Salute San Raffaele — Milan, Italy (Active_not_recruiting)
- University Federico II — Naples, Italy (Recruiting)
- IRCCS San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Michelle O'Riordan
- Email: moriordan@ucc.ie
- Phone: +353 (0)21 4901759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.