UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004730 |
|---|---|
| Receipt number | R000005631 |
| Scientific Title | Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor |
| Date of disclosure of the study information | 2010/12/15 |
| Last modified on | 2013/01/29 11:47:30 |
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Basic information
Public title
Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor
Acronym
Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor
Scientific Title
Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor
Scientific Title:Acronym
Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor
Region
| Japan |
Condition
Condition
Advanced renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is, by collecting safety and efficacy data of everolimus in patients with renal cell carcinoma as quickly as possible, to generate preliminary information on safety and efficacy of the product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
1) ORR
2) PFS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable or metastatic patients with renal cell carcinoma treated by everolimus
2) Patients who did not refuse against the provision of treatment data
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura |
Organization
Kinki University School of Medicine
Division name
Department of Urology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yoshimura |
Organization
Kinki University School of Medicine
Division name
Department of Urology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
Sponsor or person
Institute
Department of Urology, Kinki University School of Medicine
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
近畿大学(大阪府)、大阪医科大学(大阪府)、関西医科大学(大阪府)、大阪市立大学(大阪府)、大阪大学(大阪府)、京都府立医科大学(京都府)、神戸大学(兵庫県)、和歌山県立医科大学(和歌山県)、北海道大学(北海道)、山形大学(山形県)、伊勢崎市民病院(群馬県)、千葉県がんセンター(千葉県)、日本大学(東京都)、名古屋市立大学(愛知県)、藤田保健衛生大学(愛知県)、三重大学(三重県)、金沢大学(石川県)、広島大学(広島県)、徳島大学(徳島県)、愛媛大学(愛媛県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
The purpose of the study is, by collecting safety and efficacy data of everolimus in patients with renal cell carcinoma as quickly as possible, to generate preliminary information on safety and efficacy of the product. To minimize site-related biases, the investigators should collect data of all patients who have initiated everolimus treatment.
Management information
Registered date
| 2010 | Year | 12 | Month | 15 | Day |
Last modified on
| 2013 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005631
