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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008269
Receipt No. 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

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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
Institute Keio University Shool of Medicine
Department of Urology
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009748

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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