NCT06516341 Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
| NCT ID | NCT06516341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Ospedale San Raffaele |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2025-02-27 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * patients \<18 years or \> 70 years; * patients with unconfirmed both UC and CD diagnoses; * patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible; * patients unable or unwilling to sign the informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06516341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06516341 currently recruiting?
Yes, NCT06516341 is actively recruiting participants. Contact the research team at sileri.pierpaolo@hsr.it for enrollment information.
Where is the NCT06516341 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06516341 clinical trial?
NCT06516341 is sponsored by IRCCS Ospedale San Raffaele. The trial plans to enroll 35 participants.
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