UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004078 |
|---|---|
| Receipt number | 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 09:18:50 |
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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
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
n-soga@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
M-CURE
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
