UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037977 |
|---|---|
| Receipt number | R000043290 |
| Scientific Title | Bench-mark test for EndoBRAIN-02 |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2023/09/13 18:59:04 |
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Basic information
Public title
Bench-mark test for EndoBRAIN-02
Acronym
Bench-mark test for EndoBRAIN-02
Scientific Title
Bench-mark test for EndoBRAIN-02
Scientific Title:Acronym
Bench-mark test for EndoBRAIN-02
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate diagnostic performance of EB-02, a computer-aided diagnostic software for endocytoscopy, in prediction of pathology of colorectal lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess whether EB-02's performance exceeds a 90% specificity in diagnosing invasive cancer.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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. Colorectal lesions (>= 20 mm) whose images were taken with use of endocytoscopy in Digestive Disease Center, Showa University Northern Yokohama Hospital between Jan. 2016 and Jan. 2019.
2. Lesions from which >= 20 endocytoscopic pictures were taken with the appropriate staining regimen.
3. Patients' agreement is secured for provision of the images.
Key exclusion criteria
1. Severe artifacts (e.g., bubble, residuals, and halation)
2. Absence of normal endoscopy images
3. Unknown region of interest for the captured area.
4. Sessile serrated adenomas/polyps
5. insufficient staininng
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shin-ei |
| Middle name | |
| Last name | Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center,
Zip code
224-8503
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL
0459497000
ibusiginjp@hotmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center,
Zip code
224-8503
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL
0459497000
Homepage URL
ibusiginjp@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Institutional review board, Showa University Northern Yokohama Hospital
Address
irb02syh@ofc.showa-u.ac.jp
Tel
045-949-7118
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
| 2019 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective, bench-mark test using already captured endoscopic images.
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043290
