Actively Recruiting
AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
Led by University College Cork · Updated on 2024-07-18
225
Participants Needed
15
Research Sites
108 weeks
Total Duration
On this page
Sponsors
U
University College Cork
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 years and 75 years.
- Established diagnosis of Crohn's disease at least six months prior to study.
- Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.
You will not qualify if you...
- Unable to provide consent.
- Serious co-morbidities posing clinical contraindication.
- Presence of an ostomy.
- Currently pregnant or breastfeeding.
- Contraindications for colonoscopy or biopsies.
- Boston Bowel Preparation Scale Score less than 2 in the rectum plus left-sided colon.
- Allergy to nuts or shellfish (exclusion for confocal laser endomicroscopy only).
- Severe or uncontrolled asthma (exclusion for confocal laser endomicroscopy only).
- Use of beta blockers (exclusion for confocal laser endomicroscopy only).
- Previous reaction to fluorescein (exclusion for confocal laser endomicroscopy only).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of Leuven
Leuven, Belgium
Active, Not Recruiting
2
University of Calgary
Calgary, Canada
Actively Recruiting
3
University Hospital Erlangen
Erlangen, Germany
Active, Not Recruiting
4
Cork University Hospital
Cork, Ireland
Active, Not Recruiting
5
Mercy University Hospital
Cork, Ireland
Active, Not Recruiting
6
University College Dublin
Dublin, Ireland
Actively Recruiting
7
University College Hospitals Galway
Galway, Ireland
Active, Not Recruiting
8
Rabin Medical Centre
Tel Aviv, Israel
Actively Recruiting
9
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Active, Not Recruiting
10
ASST Spedali Civili
Brescia, Italy
Active, Not Recruiting
11
ASST Fatebenefratelli Sacco
Milan, Italy
Actively Recruiting
12
IRCCS Cà Granda Ospedale Maggiore
Milan, Italy
Actively Recruiting
13
University Vita-Salute San Raffaele
Milan, Italy
Active, Not Recruiting
14
University Federico II
Naples, Italy
Actively Recruiting
15
IRCCS San Matteo
Pavia, Italy
Actively Recruiting
Research Team
M
Michelle O'Riordan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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