Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
Not applicable · Testing to determine molecular and epigenetic biomarkers · 1 site · IRCCS San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing to determine molecular and epigenetic biomarkers (a procedure). Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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,
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2024-11-21.
- Main results expected around 2026-07-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- To correlate ultrasound findings with histopathological elements of lesions (1 day)
In the researchers’ words
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 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 | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | IRCCS San Raffaele |
| Enrollment | 50 (estimated) |
| Start date | 2024-11-21 |
| Primary completion (est.) | 2026-07-31 |
| First posted | 2024-07-23 |
| Last updated | 2026-01-15 |
| 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 |
| ClinicalTrials.gov ID | NCT06516237 |
Interventions
- to determine molecular and epigenetic biomarkers (Procedure)
In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Hospital, Milano | Milan, Lombardy | 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.