UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060083 |
|---|---|
| Receipt number | R000068705 |
| Scientific Title | Development of an Artificial Intelligence System for Histological Subclassification of Colorectal Serrated Lesions |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 06:54:51 |
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Basic information
Public title
Development of an Artificial Intelligence System for Histological Subclassification of Colorectal Serrated Lesions
Acronym
Colorectal Serrated Lesions AI
Scientific Title
Development of an Artificial Intelligence System for Histological Subclassification of Colorectal Serrated Lesions
Scientific Title:Acronym
Colorectal Serrated Lesions AI
Region
| Japan |
Condition
Condition
Colorectal serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an artificial intelligence system to differentiate microvesicular hyperplastic polyps from sessile serrated lesions using hematoxylin and eosin (H&E)-stained images alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic Performance of the Developed AI in Differentiating SSLs from MVHPs
Key secondary outcomes
1. Diagnostic Performance of AI for Identifying Traditional Serrated Adenomas (TSAs)
2. Diagnostic Performance of AI for Identifying Sessile Serrated Lesions with Dysplasia (SSLDs)
3. Subtype-Specific Positivity Rates of Immunohistochemical Markers, Including MIB-1, MLH1, BRAF V600E, p53, and Annexin A10
4. Prevalence of Dysplasia in Sessile Serrated Lesions (SSLs)
5. Subtype-Specific Frequency, Maximum Size, Morphology, Location, and Presence of Dysplasia in Colorectal Serrated Lesions
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with colorectal serrated lesions between May 2013 and August 2025.
Key exclusion criteria
None.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu-shi, Fukushima, Japan
TEL
0242-75-2100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kakeru |
| Middle name | |
| Last name | Otomo |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Department of Gastroenterology
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu-shi, Fukushima, Japan
TEL
0242-75-2100
Homepage URL
be59733a@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Institutional Review Board of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-shi, Japan
Tel
024-547-1825
fmucrb@fmu.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 | 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 | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will develop an artificial intelligence (AI) system to automatically diagnose serrated lesions (SSLs) using histopathological image data and evaluate its performance.
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068705
