UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004139 |
|---|---|
| Receipt number | R000004971 |
| Scientific Title | Monitoring of the lung disorder caused by the treatment of everolimus for the TKI refractory advanced RCC. |
| Date of disclosure of the study information | 2010/10/10 |
| Last modified on | 2010/08/31 19:42:37 |
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Basic information
Public title
Monitoring of the lung disorder caused by the treatment of everolimus for the TKI refractory advanced RCC.
Acronym
Monitoring of the lung disorder caused by the treatment of everolimus for the TKI refractory advanced RCC.
Scientific Title
Monitoring of the lung disorder caused by the treatment of everolimus for the TKI refractory advanced RCC.
Scientific Title:Acronym
Monitoring of the lung disorder caused by the treatment of everolimus for the TKI refractory advanced RCC.
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
early detection of the pulmonary injury caused by the everolimus.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the serum biomarkers and the findings of CT scan with early detection of pulmonary injury caused by everolimus.
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
TKI refractory advanced RCC patients.
Key exclusion criteria
everolimus hypersensitivity
pregnant female
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Graduate school of Medicine, University of Kobe
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-ku,Kobe-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Kobe
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-ku,Kobe-city
TEL
Homepage URL
Sponsor or person
Institute
Graduate school of Medicine, University of Kobe
Institute
Department
Personal name
Funding Source
Organization
NOVARTIS FARMA
Organization
Division
Category of Funding Organization
Profit 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
| 2010 | Year | 10 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not started
Management information
Registered date
| 2010 | Year | 08 | Month | 31 | Day |
Last modified on
| 2010 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004971
