Actively Recruiting

Age: 18Years - 69Years
All Genders
NCT06516341

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

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, Italy, Italy, 20132

Actively Recruiting

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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

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