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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033722
Receipt No. 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

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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
Email 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
Email sassa@med.nagoya-u.ac.jp

Sponsor
Institute Department of Urology, Nagoya University, Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038454

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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