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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041655
Receipt No. R000047256
Scientific Title Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Date of disclosure of the study information 2020/10/01
Last modified on 2020/11/10

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Basic information
Public title Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Acronym Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Scientific Title Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Scientific Title:Acronym Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Region
Japan

Condition
Condition Suspected prostate cancer
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the ability in the detection of prostate cancer in 3 types of the needle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sample quality of the prostate biopsy cores, Relationship between MRI finding and pathological findings of the prostate biopsy
Key secondary outcomes

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
Key inclusion criteria 1.Prostate cancer suspected person who are able to be receive MRI-TRUS fusion image-guided biopsy.
2.Prostate cancer suspected person with PI-RADS 4,5lesions identified on MRI.
3.Prstate cancer suspected person who agree with informed consent.
Key exclusion criteria 1.Prstate cancer suspected person who disagree with informed consent.
2.Person who are regarded as inappropriate for the study by the researcher.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Sunao
Middle name
Last name Shoji
Organization Tokai University
Division name School of Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Email sunashoj@mail.goo.ne.jp

Public contact
Name of contact person
1st name Mayura
Middle name
Last name Nakano
Organization Tokai University
Division name School of Medicine
Zip code 259-1193
Address 143 Shimokasuya,Isehara,Kanagawa
TEL 0463-93-1121
Homepage URL
Email mayura1212@gmail.com

Sponsor
Institute Tokai University
School of Medicine
Institute
Department

Funding Source
Organization Tokai University
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 Institutional Review Board for Clinical Research,Tokai University
Address 143 Shimokasuya,Isehara,Kanagawa
Tel 0463931121
Email tokai-rinsho@ml.tokai-u.jp

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
2020 Year 10 Month 01 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
2020 Year 08 Month 04 Day
Date of IRB
2020 Year 07 Month 14 Day
Anticipated trial start date
2020 Year 09 Month 23 Day
Last follow-up date
2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 09 Month 02 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047256

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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