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RECRUITING
NCT06516341

Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation

Sponsor: IRCCS Ospedale San Raffaele

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

OBSERVATIONAL

Enrollment

35

Start Date

2025-02-27

Completion Date

2026-09

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

PROCEDURE

CD patients

The study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery

PROCEDURE

UC patients

The study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Italy, Italy