Identifying biomarkers for predicting complications after surgery in inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with inflammatory bowel disease (IBD) who require surgical intervention due to inadequate response to existing therapies. The researchers aim to identify and validate specific biomarkers that may remain in the resection margins after surgery, which could indicate the risk of postoperative complications and disease recurrence. By utilizing humanized experimental models and machine learning, the study seeks to develop a predictive model for these risks, although it will not alter clinical decision-making. Patients will continue to receive standard care while being monitored throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Pierpaolo Sileri, MD. PhD.
• Email: sileri.pierpaolo@hsr.it
• Phone: +39 0226436275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.