UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011557
Receipt number R000013523
Scientific Title Urinary neurotrophic factor levels in prostate cancer patients with brachytherapy-realted overactive bladder sympton
Date of disclosure of the study information 2013/09/01
Last modified on 2017/08/27 09:13:22

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Basic information

Public title

Urinary neurotrophic factor levels in prostate cancer patients with brachytherapy-realted overactive bladder sympton

Acronym

Urinary biomarker study in brachytherapy-realted OAB

Scientific Title

Urinary neurotrophic factor levels in prostate cancer patients with brachytherapy-realted overactive bladder sympton

Scientific Title:Acronym

Urinary biomarker study in brachytherapy-realted OAB

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the urinary biomarkers in patients with sever OAB symptons following brachytherapy for prostate cancer.

Basic objectives2

Others

Basic objectives -Others

Biomarker study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To identify the urinary biomarker which correlates with voiding sympton scores.

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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male

Key inclusion criteria

Prostate cancer patients recieving brachytherapy

Key exclusion criteria

Residual urine volume >100ml
Concomitant urinary tract infection

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuichi Mizuno

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo

TEL

03-3353-1211

Email

mizunor@z7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki Shinojima

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

t-shinoj@cd5.so-net.ne.jp


Sponsor or person

Institute

Department of Urology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Keio University 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

2013 Year 09 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

Terminated

Date of protocol fixation

2013 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Preinitiation


Management information

Registered date

2013 Year 08 Month 22 Day

Last modified on

2017 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013523


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name