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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029861
Receipt No. R000034106
Official scientific title of the study Association between CTC and tumor shrinkage by TKI treatment on RCC patients
Date of disclosure of the study information 2018/11/07
Last modified on 2017/11/07

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Basic information
Official scientific title of the study Association between CTC and tumor shrinkage by TKI treatment on RCC patients
Title of the study (Brief title) Association between CTC and tumor shrinkage by TKI treatment on RCC patients
Region
Japan

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

Objectives
Narrative objectives1 To analyze the correlation between CTC and tumor shrinkage by TKI treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes number of CTC
tumor shrinkage,

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sunitinib treatment
Interventions/Control_2 Pazopanib treatment
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 metastatic clear cell renal cell carcinoma, PS; 0-1
Patients who do not have bone marrow suppression nor liver and/or renal disfunction. Patients who would have 1st line treatment.
Key exclusion criteria Who have other malignancy
Who have allergy to TKI
or pregnant
Target sample size 40

Research contact person
Name of lead principal investigator Yoshiyuki Kojima
Organization Fukushima Medical University
Division name Department of Urology
Address 1 Hikarigaoka , Fukushima
TEL 024-547-1316
Email urol@fmu.ac.jp

Public contact
Name of contact person Kei Ishibashi
Organization Fukushima Medical University
Division name Department of Urology
Address 1 Hikarigaoka , Fukushima
TEL 024-547-1316
Homepage URL
Email keikun@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization We have no conflict of Interest.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 07 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 31 Day
Anticipated trial start date
2017 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 11 Month 07 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034106

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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