UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033722 |
|---|---|
| Receipt number | R000038454 |
| Scientific Title | The evaluation of image analysis technology using artificial intelligence (AI) in urological tumor |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2018/08/11 12:41:06 |
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Basic information
Public title
The evaluation of image analysis technology using artificial intelligence (AI) in urological tumor
Acronym
The evaluation of image analysis technology using artificial intelligence (AI) in urological tumor
Scientific Title
The evaluation of image analysis technology using artificial intelligence (AI) in urological tumor
Scientific Title:Acronym
The evaluation of image analysis technology using artificial intelligence (AI) in urological tumor
Region
| Japan |
Condition
Condition
urological tumor
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To improve the diagnostic technology in urological tumors. The patients before surgery selected appropriate treatment strategy with Precise imaging diagnosis using AI (artificial intelligence).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The concordance rate between AI diagnosis and clinical diagnosis
Key secondary outcomes
The relationship with life prognosis, validity as an appropriate treatment option and examination of prognostic factors
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
In the department of urology at Nagoya university and related collaborative research hospital of it, all urinary tumor patients who underwent surgery treatment, medication treatment and diagnosis with imaging data(CT,MRI,PET and so on) and clinical examination data remain on the electronic medical records were included for the past 15 years .
Key exclusion criteria
This study using clinical data in past. Some cases that can not be pursued and cases that have already died are included. Publish research contents on the website and release information disclosure. If patients refuse to use it, patients can offer it.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokunori Yamamoto |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Tsuruma-cho 65, Showa-ku, Nagoya
TEL
052-744-2985
toku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Sassa |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Tsuruma-cho 65, Showa-ku, Nagoya
TEL
052-744-2985
Homepage URL
sassa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Nagoya University, Graduate School of Medicine
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
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 | 08 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational research in progress
Management information
Registered date
| 2018 | Year | 08 | Month | 11 | Day |
Last modified on
| 2018 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038454
| Research Plan | |
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| 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 |
