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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026709
Receipt No. R000030662
Scientific Title Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer
Date of disclosure of the study information 2017/03/27
Last modified on 2017/03/26

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Basic information
Public title Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer
Acronym Biojet system for the prostate biopsy
Scientific Title Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer
Scientific Title:Acronym Biojet system for the prostate biopsy
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and efficiency of the Biojet system against the patients suspicious of prostate cancer with high PSA levels
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The detection rate of clinically significant prostate cancer
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
50 years-old <=
Age-upper limit
95 years-old >
Gender Male
Key inclusion criteria 1) PSA level (2.8-50ng/ml)
2) Suspicious of localized prostate cancer by digital rectal examination
3) Suspicious of localized prostate cancer by MRI
4) patients who was obtained informed consent
Key exclusion criteria 1) Suspicious of invasive prostate cancer by digital rectal examination
2) Suspicious of invasive prostate cancer by MRI
3) Patients with coagulation disorder
4) Patients who can not be performed TRUS because of anal stenosis
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuzo Hamamoto
Organization Nagoya City University Graduate School of Medical Sciences
Division name Nephro-urology
Zip code
Address 1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL 052-853-8266
Email hamamo10@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuzo Hamamoto
Organization Nagoya City University Graduate School of Medical Sciences
Division name Nephro-urology
Zip code
Address 1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL 052-853-8266
Homepage URL
Email hamamo10@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Nagoya City University Hospital
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
2017 Year 03 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
2017 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information before the study

Management information
Registered date
2017 Year 03 Month 26 Day
Last modified on
2017 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030662

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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