UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057610 |
|---|---|
| Receipt number | R000065825 |
| Scientific Title | A Prospective Observational Study to Evaluate the Usefulness of Ultrasound Elastography for Non-invasive Assessment of Colonic Fibrosis and Prognosis Prediction in Ulcerative Colitis |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 00:05:42 |
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Basic information
Public title
Usefulness of Ultrasound Elastography for Predicting Colonic Fibrosis in Ulcerative Colitis (FIBROUS study)
Acronym
FIBROUS study
Scientific Title
A Prospective Observational Study to Evaluate the Usefulness of Ultrasound Elastography for Non-invasive Assessment of Colonic Fibrosis and Prognosis Prediction in Ulcerative Colitis
Scientific Title:Acronym
FIBROUS study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether ultrasound elastography can assess the degree of colonic fibrosis and correlate with clinical symptoms and histological findings in patients with ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between histological degree of fibrosis in surgical specimens and elastography values
Key secondary outcomes
Correlation between histological inflammation and ultrasound parameters such as bowel wall thickness and color Doppler signal
Association between elastography values and urgency or defecation frequency
Evaluation of intra-observer agreement in elastography measurements
Evaluation of clinical remission, endoscopic healing, histological improvement, and disease clearance
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with ulcerative colitis and aged 15 years or older
Scheduled to undergo colorectal resection including sigmoid colon or rectum by March 31, 2027
Able to undergo preoperative ultrasound elastography
Key exclusion criteria
Patients who have undergone total colectomy
Pregnant or possibly pregnant patients
Patients deemed inappropriate by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
153-0063
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
0334446161
jaken1013@gmail.com
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
08053209958
Homepage URL
jaken1013@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Shintaro Sagami
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital Research Ethics Committee Office
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
0334446161
jaken1013@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
24048
Org. issuing International ID_1
Kitasato University Kitasato Institute Hospital Research Ethics Committee Office
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective single-arm observational study aiming to evaluate the utility of ultrasound elastography for the non-invasive assessment of colonic fibrosis in patients with ulcerative colitis. Patients scheduled to undergo colorectal resection will be assessed using elastography before surgery and on the surgical specimen, and the findings will be compared with histological fibrosis grades. The study also investigates correlations between elastography findings and clinical symptoms such as urgency. A total of 30 patients are planned for inclusion.
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065825
