UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009202 |
|---|---|
| Receipt number | R000010202 |
| Scientific Title | The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease. |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2014/10/28 12:10:18 |
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Basic information
Public title
The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease.
Acronym
The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease.
Scientific Title
The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease.
Scientific Title:Acronym
The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease.
Region
| Japan |
Condition
Condition
Urothelial Carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of adverse events and theraputic effects using divided CDDP for advanced urothelial carcinoma patients with Chronic Kidney Disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The evaluation of adverse events
Key secondary outcomes
The evaluation of therapitic effects using RECIST ver 1.1
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
using divided CDDP
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
kidney function
CCr>30ml/mi,50ml/min>
Key exclusion criteria
normal kidney function
CCr 30ml/min>
insuficient function of organ
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Sassa |
Organization
Nagoya University
Division name
Urology
Zip code
Address
Tsurumai-Cho 65, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-744-2985
sassa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Sassa |
Organization
Nagoya University
Division name
Urology
Zip code
Address
Tsurumai-Cho 65, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-744-2985
Homepage URL
sassa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Univerity, Depatment of Urology
Institute
Department
Personal name
Funding Source
Organization
Nagoya Univerity, Depatment of Urology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
名古屋大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 10 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010202
