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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026520
Receipt No. R000030378
Scientific Title The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Date of disclosure of the study information 2017/03/15
Last modified on 2019/03/16

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Basic information
Public title The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Acronym The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Scientific Title The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Scientific Title:Acronym The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Region
Japan

Condition
Condition non-muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-tumor effect of enzalutamide against non-muscle invasive bladder cancer and to evaluate the safety of enzalutamide in patients with non-muscle invasive bladder cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Tumor shrinkage 4 weeks after administration
Key secondary outcomes safety

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 enzalutamide administration for four weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria pathologically diagnosed non-muscle invasive bladder cancer patients
Key exclusion criteria history of androgen deprivation therapy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Kojima
Organization Tsukuba University Hospital
Division name Urology
Zip code 305-8576
Address 2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL 029-853-3223
Email tkojima@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kawahara
Organization Tsukuba University Hospital
Division name Urology
Zip code 305-8576
Address 2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL 029-853-3223
Homepage URL
Email tkawahar99@gmail.com

Sponsor
Institute Urology department of Tsukuba University Hospital
Institute
Department

Funding Source
Organization Tsukuba University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsukuba University Hospital
Address 2-1-1, Amakubo,Tsukuba city
Tel 029-853-3914
Email rinshokenkyu@un.tsukuba.ac.jp

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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 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
2017 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030378

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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