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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000043378
Receipt No. R000049529
Scientific Title Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/19

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Basic information
Public title Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma
Acronym Monitoring for plasma concentration of sunitinib
Scientific Title Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma
Scientific Title:Acronym Monitoring for plasma concentration of sunitinib
Region
Japan

Condition
Condition metastatic renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To monitor sunitinib plasma concentration in order to bring out maximum treatment effect for the patients with metastatic renal cell carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes sunitinib plasma concentration
Key secondary outcomes progression free survival periods, rate of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Periods: to finish of sunitinib treatment
Amount: standard
Interventions/Control_2 Periods: to finish of sunitinib treatment
Amount: alternative
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1 Patients with metastatic renal cell carcinoma who have measurable regions
2 Patients who are scheduled sunitinib treatment
Key exclusion criteria 1 with liver and/or renal dysfunction (over ULNx2)
2 with severe heart failure
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kojiro
Middle name
Last name Ohba
Organization Nagasaki University Hospital
Division name Department of Urology and Renal Transplantation
Zip code 852-8501
Address Sakamoto 1-7-1, Nagasaki, Japan
TEL +81958197340
Email ohba-k@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Ohba
Organization Nagasaki University Hospital
Division name Department of Urology and Renal Transplantation
Zip code 852-8501
Address Sakamoto 1-7-1, Nagasaki, Japan
TEL +81958197340
Homepage URL
Email ohba-k@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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 Nagasaki University Hospital
Address Sakamoto 1-7-1, Nagasaki, Japan
Tel +81958197340
Email ohba-k@nagasaki-u.ac.jp

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
2021 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 64
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 Main results already published
Date of protocol fixation
2013 Year 11 Month 18 Day
Date of IRB
2013 Year 12 Month 02 Day
Anticipated trial start date
2013 Year 12 Month 02 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049529

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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