Studying markers that may predict bowel disease returning after surgery
Looks for markers that may predict recurrence in adults with colitis or Crohn disease.
Plain-language title generated from the registry record
Registry title: Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
Key facts
- Where
- Milan, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT06516341, who can take part
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Ospedale San Raffaele
- Trial code
- NCT06516341
- Record updated
- 14 March 2025
- Original description
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:Read full original descriptionShow less
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
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.
Inclusion: 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: patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible; patients <18 years or > 70 years; patients with unconfirmed both UC and CD diagnoses; patients unable or unwilling to sign the informed consent.