UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009620 |
|---|---|
| Receipt number | R000011289 |
| Scientific Title | Assessment of efficy and safety of everolimus in Japanese patients with mRCC |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2012/12/25 15:26:08 |
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Basic information
Public title
Assessment of efficy and safety of everolimus in Japanese patients with mRCC
Acronym
Assessment of efficy and safety of everolimus
Scientific Title
Assessment of efficy and safety of everolimus in Japanese patients with mRCC
Scientific Title:Acronym
Assessment of efficy and safety of everolimus
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of everolimus treatment for mRCC patients retrospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PFS, AEs
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suitable for everolimus treatment
Key exclusion criteria
Unsuitable for everolimus treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Oya M.D. |
Organization
Keio university, school of medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno M.D. |
Organization
Keio university, school of medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
mizunor@z7.keio.jp
Sponsor or person
Institute
Tokyo Afinitor Clinical Trial Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 01 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results for blood tests and radiological studies would be reviewed.
Management information
Registered date
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011289
