UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004139
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Graduate school of Medicine, University of Kobe
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.