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

NCT06516237 | Recruiting

• 1 other identifier: Strictur-US
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To correlate shear wave elastography measurements with histopathological elements of lesions

  1 day

Other Outcomes (1)

• To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution

  1 day

Study Arms (1)

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.

Procedure: to determine molecular and epigenetic biomarkers

Interventions

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.

to develop novel imaging and molecular biomarkers of fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital, Milano

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 23, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)