Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
NCT ID: NCT06516237
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-11-21
2026-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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to develop novel imaging and molecular biomarkers of fibrosis
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.
to determine molecular and epigenetic biomarkers
In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers.
Interventions
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to determine molecular and epigenetic biomarkers
In addition, up to 8 biopsies will be performed, at clinical judgment, in distal colon to determine molecular and epigenetic biomarkers.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Mariangela Allocca
Gastroenterologist
Locations
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IRCCS San Raffaele Hospital, Milano
Milan, Lombardy, Italy
Countries
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Facility Contacts
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Other Identifiers
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Strictur-US
Identifier Type: -
Identifier Source: org_study_id
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