UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055836 |
|---|---|
| Receipt number | R000063712 |
| Scientific Title | Detection Capability of Computer-Aided Detection for Depressed-Type and Laterally Spreading Colorectal Tumors: A Retrospective Study Utilizing Existing Endoscopic Data |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2025/07/01 17:37:40 |
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Basic information
Public title
Study on the impact of artificial intelligence on adenoma detection rate
Acronym
AI Study
Scientific Title
Detection Capability of Computer-Aided Detection for Depressed-Type and Laterally Spreading Colorectal Tumors: A Retrospective Study Utilizing Existing Endoscopic Data
Scientific Title:Acronym
AI Study
Region
| Japan |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
At our institution, we have developed EndoBRAIN-EYE (EB-EYE), a computer-aided detection system, and demonstrated its effectiveness. However, the utility of EB-EYE in detecting depressed-type tumors and laterally spreading colorectal tumors has not yet been evaluated. This study aims to examine the detection performance of EB-EYE for these types of lesions. Previously, EB-EYE output was displayed on a dual monitor system (with detection assistance shown on a separate screen from the endoscopic view), but it is now integrated into a single monitor system (with detection assistance displayed directly on the endoscopic screen). A retrospective comparison of adenoma detection rate (ADR) between the two systems will be conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on endoscopic data from patients who underwent colonoscopy at our institution between January 1, 2020, and December 31, 2023, we will compare the adenoma detection rate (ADR) between single monitor and dual monitor systems. Additionally, we will assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of EB-EYE in detecting depressed-type and laterally spreading tumors. Patient characteristics (age, sex, date of examination), lesion characteristics (tumor size, gross type, location, pathological diagnosis), and the adenoma detection rate (ADR) with and without the use of EB-EYE during this period will also be evaluated.
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
Inclusion Criteria:
1 Patients who underwent colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital, between January 1, 2020, and December 31, 2023.
2 Patients who did not express a refusal to participate in this study.
3 Patients aged 20 years or older at the time of examination.
Key exclusion criteria
Exclusion Criteria:
1 Patients with inflammatory bowel disease (IBD).
2 Patients with colorectal polyposis.
Target sample size
430
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | University |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35 1 Chigasakichuo Tsuzuki Ward Yokohama Kanagawa
TEL
0459497000
yuutarou-ide@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Ide |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35 1 Chigasakichuo Tsuzuki Ward Yokohama Kanagawa
TEL
0459497000
Homepage URL
yuutarou-ide@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital, Digestive Disease Center
Address
35 1 Chigasakichuo Tsuzuki Ward Yokohama Kanagawa
Tel
0459497000
yuutarou-ide@med.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
| 2024 | Year | 10 | Month | 18 | 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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A retrospective study using existing data.
Planned participation period for study subjects
Endoscopic and polyp related data will be utilized from patients who underwent colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital, between January 1, 2020, and December 31, 2023.The planned study period will extend until March 31, 2026, following approval by the Ethics Committee for Research Involving Human Subjects at Showa University and authorization from the university president to conduct the research.
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063712
