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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| to develop novel imaging and molecular biomarkers of fibrosis | Other | 50 Consecutive adult (18 years of age and older) patients, undergoing routine investigations by colonoscopy or sigmoidoscopy, will be enrolled and undergone routine biopsies in the distal colon and intestinal ultrasound with Shear wave elastography measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate ultrasound findings with histopathological elements of lesions | 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate shear wave elastography measurements with histopathological elements of lesions | 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution | To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital, Milano | Recruiting | Milan | Lombardy | 20132 | Italy |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.
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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.
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |