UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044609 |
|---|---|
| Receipt number | R000050954 |
| Scientific Title | Evaluation of computer-aided diagnosis system for colonic narrow-band imaging using artificial intelligence |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/06/21 14:23:30 |
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Basic information
Public title
Evaluation of AI-assisted diagnosis software for colonoscopy images.
Acronym
Evaluation of AI-assisted diagnosis software
Scientific Title
Evaluation of computer-aided diagnosis system for colonic narrow-band imaging using artificial intelligence
Scientific Title:Acronym
Evaluation of AI for colonic NBI images
Region
| Japan |
Condition
Condition
Colonic epithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate a CAD system that presents whether the target lesion is an adenoma, non-adenoma, or sessile serrated adenoma when non-magnified and near-magnified images of NBI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of AI for colonic adenoma (=<10mm)
Key secondary outcomes
1. Specificity, accuracy, NPV and PPV of AI for colonic adenoma (=<10mm)
2. Sensitivity, specificity, accuracy, NPV and PPV of AI for colonic non-neoplasms (=<10mm)
3. Sensitivity, specificity, accuracy, NPV and PPV of AI for colonic sesile serrated adenoma/polyp (=<10mm)
4. Sensitivity, specificity, accuracy, NPV and PPV of AI by the morphology of the 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20 years old or older at the time of examination
2. Lesions with clear NBI images
3. Lesions that have been resected and pathological diagnosis has been obtained
Key exclusion criteria
1. Patients who refuse to participate.
2. Lesions in patients with inflammatory bowel disease in a broad sense
3. Lesions not captured by NBI imaging
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa Universit Northen Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki chuo 35-1, Tsuduki, Yokohama
TEL
045-949-7000
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
Digestive Disease Center
Zip code
2248503
Address
Chigasaki-chuo 35-1, Tsuduki, Yokohama
TEL
045-949-7000
Homepage URL
mmisawa@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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
Address
Chigasaki-chuo 35-1, Tsuduki, Yokohama
Tel
045-949-7000
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Colonoscopy images taken from January 2015 to the end of June 2021 will be included in the study. A part of the images (except for the last month of the study period) will be used for training of the CAD. The lesions taken during the last month of the study period that are not used for training will be used as test images for the CAD. The test images will be selected in accordance with the following criteria. Pathological diagnosis must be obtained for the test images, but pathological diagnosis is not required for the training images.
Management information
Registered date
| 2021 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050954
