UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019278 |
|---|---|
| Receipt number | 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 17:41:17 |
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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
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
nterada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022293
