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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019278
Receipt No. R000022293
Scientific Title Clinical study of prostate cancer dagnositic makers using genetic polymorphisms
Date of disclosure of the study information 2015/10/08
Last modified on 2019/04/11

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Basic information
Public title Clinical study of prostate cancer dagnositic makers using genetic polymorphisms
Acronym Prostate cancer and genetic polymorphism
Scientific Title Clinical study of prostate cancer dagnositic makers using genetic polymorphisms
Scientific Title:Acronym Prostate cancer and genetic polymorphism
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the utility of prostate cancer risk scores using genetic polymorphisms of the patients for the diagnosis of prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The utility of prostate cancer risk scores for the detection of prostate cance by prostate biopsy
Key secondary outcomes The association of prostate cancer risk scores and the aggressiveness or prognsosis of prostate cancer

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
Key inclusion criteria Patients who reveive prostate biopsy for the diagnosis of prostate cancer.
Pathens who got the concent for the study.
Key exclusion criteria Patients who got prostate biopsy previously.
Patients harboring other cancers or receiving the treatment for other cancers.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidewaki Nakagawa
Organization RIKEN Center for Integrative Medical Sciences
Division name Laboratory for Genome Sequencing Analysis
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo,
TEL 03-5449-5785
Email hidewaki@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Terada
Organization Kyoto University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3337
Homepage URL
Email nterada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization RIKEN
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 10 Month 08 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 23 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were collected. Now under follow up.

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022293

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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