UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031430 |
|---|---|
| Receipt number | R000035833 |
| Scientific Title | Evaluation of ulcerative colitis with deep neural networks based on endoscopic images |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2019/02/25 18:24:06 |
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Basic information
Public title
Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Acronym
DNN-UC
Scientific Title
Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Scientific Title:Acronym
DNN-UC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate the varidity of deep neural networks for ulcerative colitis (DNN-UC)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
accuracy of DNN-UC to evaluate endoscopic and histological healing
Key secondary outcomes
i) ability of DNN-UC to score UCEIS
ii) accuracy of DNN-UC for endoscopic and histological healing in each segment
iii) accuracy of DNN-UC in each confidence case
iv) accuracy of DNN-UC stratified with the degree of colon cleaning.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who underwent colonoscopy for evaluation of UC
Key exclusion criteria
i) patients with prior colon surgery, IBD unclassified, Crohns disease, colorectal neoplasia, or concomitant infectious colitis
ii) patients for whom colonoscopy were contraindicated
iii) patients for whom biopsy were contraindicated because of blood disease or antithrombotic or anticoagulation therapy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Ohtsuka |
Organization
Tokyo Medical and Dental University
Division name
Department of Endoscopy
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5877
kohtsuka.gast@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kento Takenaka |
Organization
Tokyo Medical and Dental University
Division name
Department of Endoscopy
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5877
Homepage URL
ktakenaka.gast@tmd.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
the Cooperation Program between Tokyo Medical and Dental University and Sony Imaging Products & Solutions Inc.
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
Address
Tel
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
| 2018 | Year | 03 | Month | 15 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Perform colonoscopy, capture endoscopic images, and perform biopsy from each 5 segments
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035833
