IRCCS San Raffaele Hospital, Milano
Milan, Lombardy, 20132, Italy
Location status: Recruiting
Recruiting
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
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
ProcedureIn addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers.
Primary outcomes
-
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
-
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
-
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
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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