Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Procedure: to determine molecular and epigenetic biomarkers

• Registration Number: NCT06516237
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Study Start: 2024-07-31
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
to develop novel imaging and molecular biomarkers of fibrosis	to determine molecular and epigenetic biomarkers	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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