NCT06516237Recruiting
Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
Prospective multicenter interventional non-randomized cross-sectional study. Ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings. This study aims to develop novel imaging and molecular biomarkers of fibrosis, through the use of intestinal ultrasound and shear wave elastography, using histologic specimens obtained by endoscopic biopsies as reference standard.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 10 Jun 2024
- Start date
- 21 Nov 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Ulcerative colitis
- NCT number
- NCT06516237
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 21 Nov 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- subjects who needs to change therapy
Other illness
- presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare),
- poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen.
Other
- Pregnancy,
- inability to undergo intestinal ultrasound within the time set by the study,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Hospital, Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.