UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008269
Receipt number R000009748
Scientific Title Multivariate analysis of the urine spectum using with near-infrared spectroscopy for the patients performed prostate needle biopsy.
Date of disclosure of the study information 2012/07/01
Last modified on 2012/06/26 19:54:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multivariate analysis of the urine spectum using with near-infrared spectroscopy for the patients performed prostate needle biopsy.

Acronym

Analysis of the urine using with NIRS for the patients performed prostate needle biopsy.

Scientific Title

Multivariate analysis of the urine spectum using with near-infrared spectroscopy for the patients performed prostate needle biopsy.

Scientific Title:Acronym

Analysis of the urine using with NIRS for the patients performed prostate needle biopsy.

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Measuring urine spectrum of the patients performed prostate needle biopsy, and reviewing the differnce between prostate cancer patients and non-prostate cancer patients

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measuring urine spectrum of the patients performed prostate needle 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

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male

Key inclusion criteria

Patients performed prostate needle biopsy

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohiko Nagata

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address


TEL

03-5363-3825

Homepage URL


Email



Sponsor or person

Institute

Keio University Shool of Medicine
Department of Urology

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 07 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

Preinitiation

Date of protocol fixation

2012 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2012 Year 07 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

Measuring urine spectrum of the patients performed prostate needle biopsy


Management information

Registered date

2012 Year 06 Month 26 Day

Last modified on

2012 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009748