to determine molecular and epigenetic biomarkers: In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
To correlate ultrasound findings with histopathological elements of lesions — 1 day To correlate ultrasound findings with histopathological elements of lesions obtained by biopsies of the distal colon during routine investigations by colonoscopy or sigmoidoscopy, as the reference standard: specifically, Hematoxylin and Eosin (H\&E) staining for inflammation, Immunostaining of alfa-smooth muscle actin (aSMA) for muscular hypertrophy, and Sirius red special staining for collagen deposition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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