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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008141
Receipt No. R000009589
Scientific Title Establishment of therapeutic strategy for renal cell carcinoma based on the evaluation by FDG PET/CT
Date of disclosure of the study information 2012/07/01
Last modified on 2017/04/29

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Basic information
Public title Establishment of therapeutic strategy for renal cell carcinoma based on the evaluation by FDG PET/CT
Acronym Establishment of therapeutic strategy for renal cell carcinoma based on the evaluation by FDG PET/CT
Scientific Title Establishment of therapeutic strategy for renal cell carcinoma based on the evaluation by FDG PET/CT
Scientific Title:Acronym Establishment of therapeutic strategy for renal cell carcinoma based on the evaluation by FDG PET/CT
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the availability of the assessment of renal cell carcinoma by FDG PET/CT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The association of the evaluation by FDG PET/CT and progression-free survival and overall survival
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Evaluation by FDG PET/CT
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

Not applicable
Gender Male and Female
Key inclusion criteria patients with advanced renal carcinoma who were diagnosed from the results of pathological studies in principle (stage IV)
Key exclusion criteria patients who have serious illness in heart, lung, liver, or kidney
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Nakaigawa
Organization Yokohama City University
Division name Department of Urology
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa-ken
TEL 045(787)2679
Email nakaigan@medyokohama-cu.ac.jp.

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Nakaigawa
Organization Yokohama City University
Division name Department of Urology
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa-ken
TEL 045-787-2679
Homepage URL
Email urology@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 07 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 Enrolling by invitation
Date of protocol fixation
2008 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
2021 Year 03 Month 01 Day
Date trial data considered complete
2021 Year 03 Month 01 Day
Date analysis concluded
2022 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 11 Day
Last modified on
2017 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009589

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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