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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007219
Receipt No. R000008438
Scientific Title Examination of the incidence of urogenital infection with the prostate biopsy
Date of disclosure of the study information 2012/03/01
Last modified on 2014/03/03

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Basic information
Public title Examination of the incidence of urogenital infection with the prostate biopsy
Acronym Urogenital infection with the prostate bioqsy
Scientific Title Examination of the incidence of urogenital infection with the prostate biopsy
Scientific Title:Acronym Urogenital infection with the prostate bioqsy
Region
Japan

Condition
Condition Urogenital infection
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim at the protocol development by chance in validity of the antimicrobial agent administration and a solstice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of urogenital infection with 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All cases that underwent a prostate biopsy
Key exclusion criteria None
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Yamamoto
Organization Hyogo College of Medicine
Division name Department of Urology
Zip code
Address 1- 1,Mukogawa-cho,Nishinomiya,Hyogo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihkazu Togo
Organization Hyogo College of Medicine
Division name Department of Urology
Zip code
Address 1- 1,Mukogawa-cho,Nishinomiya,Hyogo
TEL
Homepage URL
Email

Sponsor
Institute Workshop of urinary tract infection
Institute
Department

Funding Source
Organization None
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 札幌医大(北海道)
筑波大(茨城県)
東京慈恵医大(東京都)
慶応大(東京都)
藤田保健衛生大(愛知県)
岐阜大(岐阜県)
兵庫医大(兵庫県)
神戸大(兵庫県)
岡山大(岡山県)
広島大(広島県)
産業医大(福岡県)
鹿児島大(鹿児島県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 08 Month 31 Day
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information retrospective study

Management information
Registered date
2012 Year 02 Month 03 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008438

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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