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

San Donato Group (GSD)

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Procedure: to determine molecular and epigenetic biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT06516237

Strictur-US

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

to develop novel imaging and molecular biomarkers of fibrosis

Other group

Description:

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.

Treatment:

Procedure: to determine molecular and epigenetic biomarkers