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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• adult (age \>18 years) patients with histologically confirmed CD or UC undergoing intestinal resection due to stricturing disease, regardless of their current or past medical treatment;

• given that it is an observational study, also pregnant and breastfeeding patients could be included;

• able and willing to sign the informed consent.

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Pierpaolo Sileri, MD. PhD.
sileri.pierpaolo@hsr.it
+39 0226436275
Backup
Federica Ungaro, PhD.
ungaro.federica@hsr.it
+39 0226437864
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2026-09
Participants
Target number of participants: 35
Treatments
UC patients
Patients with histologically confirmed UC undergoing intestinal resection due to stricturing disease. These patients will be divided into two groups:~patients with (case group) and without (control group) postoperative recurrence
CD patients
Patients with histologically confirmed CD undergoing intestinal resection due to stricturing disease. Divided into two groups: patients with (case group) and without (control group) postoperative recurrence
Sponsors
Collaborators: Ministero della Salute, Italy, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
Leads: IRCCS Ospedale San Raffaele

This content was sourced from clinicaltrials.gov