UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057596 |
|---|---|
| Receipt number | R000065808 |
| Scientific Title | Transperineal Ultrasonography in the Diagnosis and Monitoring of Rectal Inflammation in Ulcerative Colitis: A Validated AI Approach: international multicenter study ("TPUSCORE" (TransPerineal Ultrasound SCOring for Rectal Evaluation in UC)) |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2025/04/11 19:51:58 |
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Basic information
Public title
Transperineal Ultrasonography in the Diagnosis and Monitoring of Rectal Inflammation in Ulcerative Colitis: A Validated AI Approach: international multicenter study ("TPUSCORE" (TransPerineal Ultrasound SCOring for Rectal Evaluation in UC))
Acronym
TPUSCORE study
Scientific Title
Transperineal Ultrasonography in the Diagnosis and Monitoring of Rectal Inflammation in Ulcerative Colitis: A Validated AI Approach: international multicenter study
("TPUSCORE" (TransPerineal Ultrasound SCOring for Rectal Evaluation in UC))
Scientific Title:Acronym
TPUSCORE study
Region
| Japan | North America |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate a transperineal ultrasound-based scoring system for non-invasive assessment and prediction of rectal inflammation in ulcerative colitis, and to investigate its correlation with an AI-based endoscopic severity index.
Basic objectives2
Others
Basic objectives -Others
To assess the utility of transperineal ultrasound in predicting endoscopic remission.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoscopic remission at week 24 (Ulcerative Colitis Endoscopic Index of Severity =0, 1)
Key secondary outcomes
Endoscopic improvement at week 24, defined as Mayo Endoscopic Subscore zero or one
Clinical remission, defined as patient-reported outcome one or less and rectal bleeding subscore zero
Histological healing, defined as Nancy index one or less and Geboes score two point one or less
Assessment of the predictive ability of changes in TPUS parameters at week two for clinical and endoscopic outcomes at week twenty-four
Evaluation of the relationship between TPUS parameters and changes in UCEGS and UCEIS
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
Patients diagnosed with ulcerative colitis
Patients who are scheduled to initiate or modify therapy, or are under observation and will undergo endoscopy and intestinal ultrasound
Patients aged 15 years or older (including minors in some institutions)
Key exclusion criteria
Patients with a history of total colectomy
Patients who are pregnant or breastfeeding
Patients deemed inappropriate by the investigator
Target sample size
264
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
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
03-3444-6161
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
0334446161
Homepage URL
jaken1013@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment
Institute
Department
Personal name
Shintaro Sagami
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United State of America
Other related organizations
Co-sponsor
Keio University School of Medicine, Endoscopy Center
Mayo Clinic Arizona, Division of Gastroenterology
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
24049
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 | 11 | 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 | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective and prospective observational study aiming to develop and validate a novel transperineal ultrasound (TPUS) scoring system for assessing rectal inflammation in patients with ulcerative colitis. The retrospective phase uses stored endoscopic and TPUS data to establish correlations with the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). The prospective phase evaluates changes in TPUS parameters at weeks 0, 2, and 24 in relation to treatment outcomes. The study also investigates the correlation between TPUS findings and an artificial intelligence-based endoscopic grading system (UCEGS).
Management information
Registered date
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065808
