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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019267
Receipt No. R000022279
Scientific Title The analysis of CTC in CRPC patients
Date of disclosure of the study information 2015/12/21
Last modified on 2018/10/10

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Basic information
Public title The analysis of CTC in CRPC patients
Acronym The analysis of CTC in CRPC patients
Scientific Title The analysis of CTC in CRPC patients
Scientific Title:Acronym The analysis of CTC in CRPC patients
Region
Japan

Condition
Condition CRPC
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The correlation between CTC and clinical parameters in CRPC patients
Basic objectives2 Others
Basic objectives -Others Analysis of the expression
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes CTC count
etc
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 doxetaxel
cabazitaxel
abiraterone
enzalutamide
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
30 years-old <=
Age-upper limit
100 years-old >=
Gender Male
Key inclusion criteria CRPC confirmed
Key exclusion criteria Uncontroled general complication.
etc
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Kosaka
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email takemduro@a6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Kosaka
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email takemduro@a6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization self funding
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
2015 Year 12 Month 21 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 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

Management information
Registered date
2015 Year 10 Month 07 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022279

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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