System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT06516237 on ClinicalTrials.gov

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

Official 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

  • Sponsor: IRCCS Ospedale San Raffaele
  • Enrollment: 50 (Estimated)
  • Study start: 2024-11-21 (Actual)
  • Primary completion: 2026-07-31 (Estimated)
  • Study completion: 2026-07-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: Other

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

Intervention / Treatment

  • Procedure: to determine molecular and epigenetic biomarkers

Primary Outcome Measures

  • 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

Countries

Italy

Locations and Investigators