Crohn'sUCRecruiting
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
Observational · No treatment assigned · 1 site · IRCCS Ospedale San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 69
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 35 participants are expected to take part.
- Start date: 2025-02-27.
- Main results expected around 2025-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- To define spatial, cellular, and molecular characteristics of IBD-derived intestinal samples (6 months from surgery)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis; Crohn Disease |
| 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 |
| Enrollment | 35 (estimated) |
| Start date | 2025-02-27 |
| Primary completion (est.) | 2025-09 |
| First posted | 2024-07-23 |
| Last updated | 2025-03-14 |
| Official title | Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation |
| ClinicalTrials.gov ID | NCT06516341 |
Interventions
- CD patients (Procedure)
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 - UC patients (Procedure)
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
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan, Italy | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.