UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007219
Receipt number 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 14:08:38

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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 or person

Institute

Workshop of urinary tract infection

Institute

Department

Personal name



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

Value
https://center6.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