UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050543 |
|---|---|
| Receipt number | R000057559 |
| Scientific Title | Clinical usefulness of artificial intelligence for the diagnosis using magnifying endoscopy with narrow-band imaging |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2023/09/08 13:42:43 |
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Basic information
Public title
Clinical usefulness of artificial intelligence for the diagnosis using magnifying endoscopy with narrow-band imaging
Acronym
AI for M-NBI
Scientific Title
Clinical usefulness of artificial intelligence for the diagnosis using magnifying endoscopy with narrow-band imaging
Scientific Title:Acronym
AI for M-NBI
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating the diagnostic performance of artificial intelligence for the gastric mucosal lesion which is observed by magnifying endoscopy with narrow-band imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specificity for the diagnosis of early gastric cancer by artificial intelligence
Key secondary outcomes
Sensitivity, accuracy, positive predictive value, negative predictive value and AUC for the diagnosis of early gastric cancer by artificial intelligence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endoscopic images which were captured and recorded using magnifying endoscopy with narrow-band imaging in Fukuoka University Chikushi Hospital
Key exclusion criteria
Endoscopic images whose quality is not enough for the analysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin Chikushno-city Fukuoka, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin Chikushno-city Fukuoka, Japan
TEL
092-921-1011
Homepage URL
yao@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Others
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
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma Jonan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2023 | Year | 03 | Month | 09 | 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
| 2022 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular.
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057559
