New imaging and molecular tests to detect bowel fibrosis in ulcerative colitis
Official title: Relationships Between Intestinal Ultrasound Parameters and Elastography Measurements With Histopathologic Findings in a Prospective Cohort of Patients With Ulcerative Colitis: Development of Novel Imaging and Molecular Biomarkers of Fibrosis
Run by IRCCS San Raffaele · NCT06516237 · Data updated 2026-11-12
We will test whether intestinal ultrasound with shear wave elastography plus molecular markers from biopsy can detect fibrosis in adults with ulcerative colitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | November 21, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT06516237 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with an established diagnosis of ulcerative colitis who are scheduled for colonoscopy and can undergo intestinal ultrasound and biopsy are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have ascites or active infections, cannot undergo colonoscopy or timely ultrasound, have poor-quality ultrasound windows, a malignant pathology, or require an immediate therapy change are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized cross-sectional study comparing intestinal ultrasound and shear wave elastography to histology from endoscopic biopsies. Ultrasound operators will be blinded to clinical and endoscopic findings, and the endoscopist will be blinded to clinical and ultrasound findings. Collected biopsy tissue will also undergo molecular and epigenetic analyses to search for fibrosis biomarkers. Eligible participants are adults with established ulcerative colitis who are undergoing colonoscopy per standard care.
Why it matters
Potential benefit: If successful, the approach could enable earlier, less invasive detection of intestinal fibrosis to better guide treatment choices and reduce unnecessary surgery.
How similar studies have gone: Ultrasound and elastography have shown promise for assessing bowel stiffness in inflammatory bowel disease, especially Crohn's disease, but combining imaging with molecular and epigenetic markers for ulcerative colitis fibrosis is largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult, 18 years of age and older, * Established diagnosis (\> three months) of ulcerative colitis, * Performing colonoscopy, according to current standards of care and ECCO guidelines, * Ability to understand and comply with the study procedure and sign an informed consent form Exclusion Criteria: * Pregnancy, * presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare), * inability to undergo intestinal ultrasound within the time set by the study, * poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen. * subjects who needs to change therapy
Where it's running
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IRCCS San Raffaele Hospital, Milano
Milan, Lombardy, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.