UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058862 |
|---|---|
| Receipt number | R000067250 |
| Scientific Title | Validation of an Automatic Report Generation AI for Colonoscopy: A Single-center Retrospective Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/08/18 10:38:10 |
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Basic information
Public title
Evaluation of the Accuracy of AI-generated Colonoscopy Reports
Acronym
Colonoscopic AI Report Validation Study
Scientific Title
Validation of an Automatic Report Generation AI for Colonoscopy: A Single-center Retrospective Study
Scientific Title:Acronym
Colonoscopic AI Report Validation Study
Region
| Japan |
Condition
Condition
Colorectal neoplastic lesions, non-neoplastic colorectal lesions, colorectal cancer, adenoma, hyperplastic polyp, sessile serrated lesion (SSL), inflammatory bowel disease, normal colonic mucosa
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic performance and validity of AI-generated colonoscopy reports, and to clarify their usefulness for diagnostic support and report standardization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement rate between AI-generated reports and physicians'reports (diagnostic concordance rate)
Key secondary outcomes
･Sensitivity, specificity, and accuracy for neoplastic, non-neoplastic, SSL, and cancer lesions
･Processing time for AI-generated reports
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
1. Patients who underwent colonoscopy at Showa University Northern Yokohama Hospital between January 2015 and July 2025
2. Age>=18 years
3. Cases with available endoscopic images, reports, and pathological results
4. Patients who did not opt out of the use of their images for AI research
Key exclusion criteria
1. Cases in which no images were recorded during colonoscopy
2. Patients who opted out of the use of their images for AI research
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Showa University Northern Yokohama Hospital, Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa 224-8503, Japan
TEL
045-949-7000(7841)
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Showa University Northern Yokohama Hospital, Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa 224-8503, Japan
TEL
045-949-7000(7841)
Homepage URL
mmisawa@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital, Digestive Disease Center
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
Institutional Review Board, Showa University Northern Yokohama Hospital
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa 224-8503, Japan
Tel
045-949-7000
m-rinri@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 single-center retrospective observational study including patients who underwent colonoscopy at Showa University Northern Yokohama Hospital between January 1, 2015 and July 31, 2025. Existing colonoscopy images, endoscopic reports, and pathological results will be used to evaluate the validity of AI-generated endoscopic descriptions. No new examinations, treatments, or interventions will be performed; only data obtained during routine clinical practice will be analyzed. All data will be anonymized prior to analysis, ensuring that no individual can be identified.
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067250
