UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044952 |
|---|---|
| Receipt number | R000051347 |
| Scientific Title | Evaluation of assistive system of histological remission diagnosis of ulcerative colitis by magnified NBI image using artificial intelligence |
| Date of disclosure of the study information | 2021/07/27 |
| Last modified on | 2022/01/27 11:56:53 |
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Basic information
Public title
Evaluation of assistive system of histological remission diagnosis of ulcerative colitis by magnified NBI image using artificial intelligence
Acronym
Evaluation of diagnostic assistance system using enlarged NBI images
Scientific Title
Evaluation of assistive system of histological remission diagnosis of ulcerative colitis by magnified NBI image using artificial intelligence
Scientific Title:Acronym
Evaluation of diagnostic assistance system using enlarged NBI images
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop and evaluate a diagnostic assistance system using artificial intelligence that can diagnose histological remission using magnified NBI images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the percentage of histological inflammation by AI diagnostic output
Key secondary outcomes
Clinical relapse rate after 1 year by diagnosis of AI diagnostic output
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a definite diagnosis of ulcerative colitis in advance
Patients undergoing lower gastrointestinal endoscopy due to clinical need
Patients who are 20 years of age or older at the time of consent acquisition
Patients with no history of radiation therapy for the abdomen or pelvis
Key exclusion criteria
Patients who have been asked to refuse to participate in this study
Patients who did not undergo histological diagnosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YASUHARU |
| Middle name | |
| Last name | MAEDA |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL
+81459497000
yasuharumaeda610@hotmail.com
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
2248503
Address
35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL
+81459497000
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Showa University Northern Yokohama Hospital Digestive Disease Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital Digestive Disease Center
Address
35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
Tel
+81459497000
yasuharumaeda610@hotmail.com
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
| 2021 | Year | 07 | Month | 27 | 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
| 2021 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Develop and evaluate a diagnostic assistance system using artificial intelligence that can diagnose histological remission using magnified NBI images
Management information
Registered date
| 2021 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051347
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
