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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023553
Receipt No. R000026760
Scientific Title The multicenter clinical test which considers predictive risk factors of acute kidney injury after chemotherapy including cisplatinun
Date of disclosure of the study information 2016/10/01
Last modified on 2016/07/18

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Basic information
Public title The multicenter clinical test which considers predictive risk factors of acute kidney injury after chemotherapy including cisplatinun
Acronym predictive risk factors of AKI after chemotherapy including CDPP
Scientific Title The multicenter clinical test which considers predictive risk factors of acute kidney injury after chemotherapy including cisplatinun
Scientific Title:Acronym predictive risk factors of AKI after chemotherapy including CDPP
Region
Japan

Condition
Condition Urothelial cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluated the predictive risk factors of AKI after chemotherapy including CDDP
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the presence or absence of AKI after CDDP chemotherapy
Key secondary outcomes the predictive risk factors of AKI after chemotherapy including CDDP

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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients with urothelial cancer with chemotherapy including CDDP
first-pearson informed consent
Key exclusion criteria patient with maintenance HD therapy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SATORU MUTO
Organization Teikyo University School of Medicine
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL 0339641211
Email urology@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name SATORU MUTO
Organization Teikyo Universith School of Medicine
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL 0339641211
Homepage URL
Email urology@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo Universith School of Medicine
Institute
Department

Funding Source
Organization Teikyo Universith School of Medicine
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
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
2016 Year 10 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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 none

Management information
Registered date
2016 Year 08 Month 09 Day
Last modified on
2016 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026760

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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