Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06516237

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

Led by IRCCS San Raffaele · Updated on 2026-01-15

50

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult, 18 years of age and older
  • Established diagnosis (> three months) of ulcerative colitis
  • Scheduled to undergo colonoscopy according to current standards of care and ECCO guidelines
  • Ability to understand and comply with the study procedures and sign an informed consent form
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Presence of ascites, active infections, or 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
  • Diagnosis of malignancy in the pathological specimen
  • Need to change therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele Hospital, Milano

Milan, Lombardy, Italy, 20132

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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