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NCT Number: NCT06516237

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

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Hospital, Milano

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. To correlate ultrasound findings with histopathological elements of lesions

    Time frame: 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 outcomes

  1. To correlate shear wave elastography measurements with histopathological elements of lesions

    Time frame: 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

Other outcomes

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

    Time frame: 1 day

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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Relationships Between Intestinal Ultrasound Parameters and Elastography Measurements With Histopathologic Findings in a Prospective Cohort of Patients With Ulcerative Colitis: Development of Novel Imaging and Molecular Biomarkers of Fibrosis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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