UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011893 |
|---|---|
| Receipt number | R000013885 |
| Scientific Title | Efficacy of therapeutic drug monitoring of mTOR inhibitor (Everolimus) in patients with renal cell carcinoma |
| Date of disclosure of the study information | 2013/09/28 |
| Last modified on | 2013/09/27 16:35:23 |
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Basic information
Public title
Efficacy of therapeutic drug monitoring of mTOR inhibitor (Everolimus) in patients with renal cell carcinoma
Acronym
Efficacy of therapeutic drug monitoring of mTOR inhibitor (Everolimus) in patients with renal cell carcinoma
Scientific Title
Efficacy of therapeutic drug monitoring of mTOR inhibitor (Everolimus) in patients with renal cell carcinoma
Scientific Title:Acronym
Efficacy of therapeutic drug monitoring of mTOR inhibitor (Everolimus) in patients with renal cell carcinoma
Region
| Japan |
Condition
Condition
Metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between efficacy and blood concentration of Everolimus in patients with renal cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between efficacy and blood concentration of Everolimus
Key secondary outcomes
The relationship between adverse events and blood concentration of Everolimus
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
1. Patients over 20 years old
2. Patients diagnosed unresectable or metastatic renal cell carcinoma who have already treated at least with 1 TKI
3. Patients who understand the study and signed the informed consent forms
Key exclusion criteria
1. Patients in contraindication
2. Patients with hepatic function disorder
3. Patients diagnosed as interstitial pneumonia
4. Patients who have already treated with Everolimus
5. Patients who are judged as inadequate by doctor in attendance
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Yamaguchi |
Organization
Osaka General Medical Center
Division name
Department of Urology
Zip code
Address
3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-8558, Japan
TEL
06-6692-1201
syamaguchi@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Tsutahara |
Organization
Osaka General Medical Center
Division name
Department of Urology
Zip code
Address
3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-8558, Japan
TEL
06-6692-1201
Homepage URL
tsutahara@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪府立急性期・総合医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 28 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
Everolimus and blood concentration, prospective study
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013885
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| Registered date | File name |
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| Registered date | File name |
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