UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038547 |
|---|---|
| Receipt number | R000043837 |
| Scientific Title | computer-aided diagnostic system for endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2020/06/09 15:02:43 |
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Basic information
Public title
computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Acronym
EndoBRAIN-UC STUDY
Scientific Title
computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Scientific Title:Acronym
EndoBRAIN-UC STUDY
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of computer-aided diagnosis software(EB-03) using colonoscopy still image database.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of computer-aided diagnosis software(EB-03) for the presence of histological
inflammation (Geboes score 3.1 or more)
Key secondary outcomes
The sensitivity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)
The specificity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)
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
1)Pts with ulcerative colitis who were underwent with endocytoscopy at Showa University Yokohama Northern Hospital between October 2016 and December 2017.
2)Pts with informed consent.
Key exclusion criteria
1)Pts whose examination video is not saved.
Target sample size
40
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
Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL
045-949-7000
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL
045-949-7468
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Showa University Northern Yokohama Hospital
Address
Chigasaki-chuo 35-1, Tsuduki-ku, 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
| 2019 | Year | 11 | Month | 12 | 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
42
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 | 08 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective study using still image data base.
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043837
