Ulcerative Colitis
Conditions
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.
Interventions
PROCEDUREto 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.
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Ultrasound and endoscopy will be performed within 7 days in blinded fashion, where the ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings.
Intervention model description
50 Consecutive adult (18 years of age and older) patients with an established diagnosis (\> 3 months) of ulcerative colitis irrespective to state of disease and treatment, undergoing routine investigations by colonoscopy or sigmoidoscopy(according to the current standard of care indications and ECCO guidelines), will be enrolled and undergone routine biopsies in the distal colon and intestinal ultrasound with Shear wave elastography measurements. In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers. Any medication will be kept stable in the interval between the two procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To correlate shear wave elastography measurements with histopathological elements of lesions | 1 day | To correlate shear wave elastography measurements with histopathological elements of lesions, 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution | 1 day | To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution |
Countries
Italy
Outcome results
None listed