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

NCT06516341 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

    collaborator UNKNOWN

  • Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

    collaborator OTHER

  • Ministero della Salute, Italy

    collaborator OTHER

  • IRCCS Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516341 on ClinicalTrials.gov