Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
Recruiting · NCT06516237 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
to determine molecular and epigenetic biomarkers
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- IRCCS San Raffaele Hospital, Milano - Milan, Lombardy, Italy