UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060537 |
|---|---|
| Receipt number | R000069248 |
| Scientific Title | Development of an Artificial Intelligence Based Diagnostic Support System for Endoscopic Remission in Ulcerative Colitis |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 17:19:53 |
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Basic information
Public title
Development of an Artificial Intelligence Based Diagnostic Support System for Endoscopic Remission in Ulcerative Colitis
Acronym
AI system for ulcerative colitis
Scientific Title
Development of an Artificial Intelligence Based Diagnostic Support System for Endoscopic Remission in Ulcerative Colitis
Scientific Title:Acronym
AI system for ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to improve the diagnostic accuracy and evaluate the generalizability of an artificial intelligence-based software system for endoscopic remission in ulcerative colitis using colonoscopy images collected from multiple institutions. This study aims to establish a standardized diagnostic support system independent of endoscopist experience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy, sensitivity, and specificity of the diagnostic support software for endoscopic remission (Mayo endoscopic subscore 1 or less) and complete endoscopic remission (Mayo endoscopic subscore 0) compared with expert endoscopist assessments.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with a confirmed diagnosis of ulcerative colitis who undergo colonoscopy as part of routine clinical practice.
Key exclusion criteria
Patients who refuse to participate in this study
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Shin-ei |
| Middle name | |
| Last name | Kudo |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1chigasaki-chuo, Tzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
0459497000
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1chigasaki-chuo, Tzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
0459497000
Homepage URL
yasuharu@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Showa Medical University Northern Yokohama Hospital
Address
35-1 Chigasaki-chuo, Tsuzuki, Yokohama, Japan
Tel
0459497000
irb02syh@ofc.showa-u.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
昭和医科大学横浜市北部病院(神奈川県) 慶応義塾大学病院(東京都) 東京科学大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2021 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 multicenter observational study without intervention. Anonymized colonoscopy images obtained during routine clinical practice are collected and used to develop and evaluate an artificial intelligence-based diagnostic support software for endoscopic remission in ulcerative colitis.
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069248
