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

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated March 14, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Sep 2024 to Feb 27, 2025
    • Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study site revised
    • Collaborators expanded, about 19 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06516341
Lead Sponsor IRCCS Ospedale San Raffaele
Collaborators: IRCCS Casa Sollievo della Sofferenza, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Ministero della Salute, Italy
Conditions
(from sponsor)
Ulcerative Colitis, Crohn Disease
Related terms Colitis, Ulcerative, Constriction, Pathologic, Crohn Disease
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov