Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: to determine molecular and epigenetic biomarkers.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- To correlate ultrasound findings with histopathological elements of lesions [Time frame: 1 day]
Secondary outcome measures (1)
- To correlate shear wave elastography measurements with histopathological elements of lesions [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- IRCCS San Raffaele Hospital, Milano — Milan
Identifiers
NCT: NCT06516237 · Strictur-US