UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060073 |
|---|---|
| Receipt number | R000068680 |
| Scientific Title | Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis. |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 18:00:38 |
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Basic information
Public title
Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.
Acronym
Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.
Scientific Title
Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.
Scientific Title:Acronym
Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing endoscopic inflammation in ulcerative colitis (UC) is challenging because the mucosal appearance varies widely depending on the degree of inflammation. In current clinical practice, endoscopists evaluate inflammatory activity using scoring systems such as the Mayo Endoscopic Subscore (MES) and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS); however, substantial inter-observer variability and limited intra-observer reproducibility remain well-recognized issues.
To enable more objective and accurate assessment in daily practice, we have developed a novel artificial intelligence (AI) system capable of grading inflammatory severity on a continuous 0-10 scale, termed the Ulcerative Colitis Endoscopic Gradation Scale (UCEGS). Unlike conventional scoring systems, this AI model evaluates the degree of inflammation itself without being constrained by predefined categorical criteria. In preclinical validation using selected high-quality images, the AI-derived UCEGS demonstrated strong concordance with assessments by IBD experts, with a Spearman correlation coefficient exceeding 0.95.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the agreement between the AI-based assessment (UCEGS) and the diagnosis made by IBD experts using the Mayo Endoscopic Subscore (MES), which serves as the gold standard, by calculating Cohen's kappa coefficient.
Expert diagnosis: MES 0-1 is defined as remission, and MES 2-3 is defined as active.
AI diagnosis: a UCEGS value <5.3 is defined as remission, and a value >=5.3 is defined as active.
Key secondary outcomes
Correlation and agreement between the AI assessment (UCEGS) and histological evaluation.
Correlation between clinical outcomes and changes in UCEGS values over time.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ulcerative colitis who are scheduled to undergo lower gastrointestinal endoscopy.
Patients aged 18 years or older at the time of consent.
Patients who can provide written informed consent to participate in this study.
Key exclusion criteria
Patients with a history of total colectomy.
Patients deemed inappropriate for participation in this study at the discretion of the investigator.
Patients who withdraw their consent to participate in the study after registration.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine, Tokyo, Japan
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Shoma |
| Middle name | |
| Last name | Murata |
Organization
Keio University School of Medicine, Tokyo, Japan
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
shomamurata@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
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 | 12 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068680
