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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009202
Receipt No. 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

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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
Last 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
Email sassa@med.nagoya-u.ac.jp

Public contact
1st 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
Email sassa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Univerity, Depatment of Urology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010202

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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