Actively Recruiting
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
Led by IRCCS Ospedale San Raffaele · Updated on 2025-03-14
35
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
I
IRCCS Ospedale San Raffaele
Lead Sponsor
I
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
Collaborating Sponsor
AI-Summary
What this Trial Is About
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made: 1. defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors 2. integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care. This project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.
CONDITIONS
Official Title
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old with confirmed Crohn's disease or ulcerative colitis undergoing intestinal surgery due to stricturing disease
- Pregnant or breastfeeding patients may be included
- Able and willing to sign informed consent
You will not qualify if you...
- Patients younger than 18 years or older than 69 years
- Patients without confirmed Crohn's disease or ulcerative colitis diagnosis
- Patients with dysplasia or cancer diagnosis or surgeries where postoperative endoscopic evaluation is not possible
- Patients unable or unwilling to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
P
Pierpaolo Sileri, MD. PhD.
CONTACT
F
Federica Ungaro, PhD.
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
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here