UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019267
Receipt number 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 16:50:05

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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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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