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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004078
Receipt No. R000004910
Scientific Title The impact of the amount of survivin in the dropping cells during nephroureterectomy with bladder cuff for the bladder cancer recurrence in upper urinary cancer
Date of disclosure of the study information 2010/08/20
Last modified on 2012/02/20

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Basic information
Public title The impact of the amount of survivin in the dropping cells during nephroureterectomy with bladder cuff for the bladder cancer recurrence in upper urinary cancer
Acronym Survivin BT
Scientific Title The impact of the amount of survivin in the dropping cells during nephroureterectomy with bladder cuff for the bladder cancer recurrence in upper urinary cancer
Scientific Title:Acronym Survivin BT
Region
Japan

Condition
Condition upper urinary cancer cases with the plan received nephroureterectomy with bladder cuff
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation between the amount of survivin and bladder recurrence

Basic objectives2 Others
Basic objectives -Others 1) To calculate the amount of survivin in the dropping cells during operation
2) To evaluate the correlation between the amount of survivin and bladder recurrence

Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The correlation between non-bladder recurrence ratio and the amount of survivin

Key secondary outcomes The correlation between over all survival and the account of survivin
The correlation between non- recurrence ratio (except for baldder) and the account of survivin
The correlation between cause specific survival ratio and the amount of survivin
The correlation between progression free survival ratio and the amount of survivin


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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria upper urinary cancer cases with the plan received nephroureterectomy with bladder cuff, any staging, any pathological result
Key exclusion criteria can not receive consensus to entry to this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki sugimura
Organization Mie university
Division name urology
Zip code
Address Edobashi 2-174, Tsu, Mie, Japan
TEL 059-232-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Soga
Organization Mie university
Division name urology
Zip code
Address Edobashi 2-174, Tsu, Mie, Japan
TEL 059-232-1111
Homepage URL
Email n-soga@clin.medic.mie-u.ac.jp

Sponsor
Institute M-CURE
Institute
Department

Funding Source
Organization Mie university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2010 Year 08 Month 20 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
2009 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information 1)to calculate the amount of survivin in the dropping cells during operation 2)bladder recurrence
3)recurrence except for bladder
4)survival

Management information
Registered date
2010 Year 08 Month 20 Day
Last modified on
2012 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004910

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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