UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008141 |
|---|---|
| Receipt number | 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 15:03:54 |
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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
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
urology@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009589
