NCT06516237 Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
| NCT ID | NCT06516237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-21 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06516237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06516237 currently recruiting?
Yes, NCT06516237 is actively recruiting participants. Visit ClinicalTrials.gov or contact IRCCS San Raffaele to inquire about joining.
Where is the NCT06516237 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06516237 clinical trial?
NCT06516237 is sponsored by IRCCS San Raffaele. The trial plans to enroll 50 participants.
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