UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032476 |
|---|---|
| Receipt number | R000037031 |
| Scientific Title | Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients using endocytoscopy |
| Date of disclosure of the study information | 2018/05/06 |
| Last modified on | 2022/05/16 20:28:41 |
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Basic information
Public title
Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients using endocytoscopy
Acronym
Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients
Scientific Title
Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients using endocytoscopy
Scientific Title:Acronym
Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients
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 develop and evaluate a computer-aided diagnosis system for histological inflammatory severity of UC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in segment-based analysis.
Key secondary outcomes
Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in segments with mucosal healing.
Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in patient-based analysis.
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
UC patients who were taken biopsy after observation with endocytoscopy
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuharu Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497567
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497567
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants in Aid for Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
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 | 05 | Month | 06 | 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 | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
endoscopic images are allocated to an automated diagnosis sysetm and endoscopists for assessment of accuracy of pathological prediction.
Diganostic accuracies, and confidence levels are evaluated.
Management information
Registered date
| 2018 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037031
