UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049564 |
|---|---|
| Receipt number | R000055272 |
| Scientific Title | Influence of Computer Aided Diagnosis System on Endoscopist's Diagnostic Accuracy in Diagnosing Colorectal Polyps -A prospective observational study using still images- |
| Date of disclosure of the study information | 2022/11/20 |
| Last modified on | 2023/01/14 17:09:10 |
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Basic information
Public title
A study to determine how artificial intelligence assistance affects the accuracy of a physician's diagnosis of colorectal polyps.
Acronym
A study to determine how artificial intelligence assistance affects the accuracy of a physician's diagnosis of colorectal polyps.
Scientific Title
Influence of Computer Aided Diagnosis System on Endoscopist's Diagnostic Accuracy in Diagnosing Colorectal Polyps
-A prospective observational study using still images-
Scientific Title:Acronym
Influence of Computer Aided Diagnosis System on Endoscopist's Diagnostic Accuracy in Diagnosing Colorectal Polyps
-A prospective observational study using still images-
Region
| Japan |
Condition
Condition
Colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, polyp images of patients who underwent colonoscopy at the Digestive Disease Center of Showa University Northern Yokohama Hospital will be used, and endoscopists will read and diagnose whether the polyps are neoplastic or nonneoplastic. This study will be conducted twice to compare the diagnostic accuracy of NBI-CAD without NBI-CAD in the first session and with NBI-CAD in the second session, and to verify the effect of NBI-CAD on the diagnostic accuracy of NBI-CAD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To test whether the sensitivity of physicians to neoplastic lesions is improved by the use of AI with statistical significance.
Key secondary outcomes
1. physician's specificity, accuracy, PPV, and NPV for neoplastic lesions
2. sensitivity, specificity, accuracy, PPV, and NPV of neoplastic lesions less than 5 mm when the physician diagnosed with high confidence
3. percentage of lesions that the physician could diagnose with high confidence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The lesion images will be endoscopic images of polyps for which the pathological diagnosis has been confirmed in patients who underwent colonoscopy at the Digestive Organs Center of Showa University Northern Yokohama Hospital between July 2021 and January 2022.
The order in which the images were displayed for the first and second reading, as well as for each physician, was randomly sorted by random number generation.
The NBI-CAD used in this study is based on the AI developed in a previous study (Showa University Northern Yokohama Hospital, Ethics Committee No. 20H048), and the images used for machine learning were those taken by the end of June 2021. The NBI image (Olympus narrow-band light mode) can be input and analyzed to determine whether the lesion is neoplastic or non-neoplastic. If there is no lesion in the image, if the lesion is present but the image is blurred, or if the lesion is present but distant and small, "Not a good sample" or "Blur image" will be displayed and no support result will be output.
The researcher will display a predesigned sample size of anonymized lesion images on a stand-alone computer, and while viewing the lesion images, the user will enter whether the lesion is tumor or non-tumor, along with the level of confidence (high confidence or low confidence) of the diagnosis. The NBI-CAD results are not displayed at that time. The physicians reading the images were 7 endoscopists and 7 non-endoscopists based on the number of sample sizes.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Epithelial lesions of the colon measuring 10 mm or less in diameter imaged at the Digestive Disease Center, Showa University Northern Yokohama Hospital from July 1, 2021 to the end of January, 2022
2. lesions taken from patients who have not expressed their refusal to participate in this study
3. lesions taken from patients who were 20 years of age or older at the time of examination
Key exclusion criteria
1. lesions for which no NBI images have been captured
2. lesions for which the NBI images taken are too blurred to be annotated
3. lesions for which only images showing multiple lesions were taken
4. lesions imaged from patients with inflammatory bowel disease
5. lesion imaged from a patient with polyposis
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
ShowaUniversityNorthernYokohamaHospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City
TEL
0459497000
misawaanny@gmail.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
ShowaUniversityNorthernYokohamaHospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City
TEL
0459497000
Homepage URL
misawaanny@gmail.com
Sponsor or person
Institute
ShowaUniversityNorthernYokohamaHospital
Institute
Department
Personal name
Funding Source
Organization
no
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
ShowaUniversity
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
0337848000
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
| 2022 | Year | 11 | Month | 20 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055272
