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Recruitment status Terminated
Unique ID issued by UMIN UMIN000007081
Receipt No. R000008337
Scientific Title A Study of prediction of onset and course of interstitial pneumonitis for treated advanced renal cell carcinoma with mTOR inhibitor(everolimus or temsirolimus) by measurement of fraction of exhaled nitric oxide
Date of disclosure of the study information 2012/01/17
Last modified on 2014/10/11

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Basic information
Public title A Study of prediction of onset and course of interstitial pneumonitis for treated advanced renal cell carcinoma with mTOR inhibitor(everolimus or temsirolimus) by measurement of fraction of exhaled nitric oxide
Acronym A Study of prediction of onset and course of interstitial pneumonitis by measurement of fraction of exhaled nitric oxide
Scientific Title A Study of prediction of onset and course of interstitial pneumonitis for treated advanced renal cell carcinoma with mTOR inhibitor(everolimus or temsirolimus) by measurement of fraction of exhaled nitric oxide
Scientific Title:Acronym A Study of prediction of onset and course of interstitial pneumonitis by measurement of fraction of exhaled nitric oxide
Region
Japan

Condition
Condition Inoperable or metastatic renal cell carcinoma treated with mTOR inhibitor (everolimus or temsirolimus)
Classification by specialty
Pneumology Nephrology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exhaled NO measurement is performed in patients with inpoperable or metastatic renal cell carcinoma treated with mTOR inhibitor (everolimus or temsirolimus), consider whether we can predict the onset and course of interstitial lung disease.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between exhaled NO and interstial pneumonia in the course of mTOR inhibitor therapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)written informed consent
2)patients performed pulmonary function tests
Key exclusion criteria 1)not written informed consent
2)patients with pulmonary function testing can not be done
3)bronchial asthma patients
4)smoker
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Imamura
Organization Osaka medical center for cancer and cardiovascular diseases
Division name Pulmonary oncology
Zip code
Address 1-3-3 nakamichi higashinari-ku, Osaka 537-8511
TEL 06-6972-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Nishino
Organization Osaka medical center for cancer and cardiovascular diseases
Division name Pulmonary oncology
Zip code
Address 1-3-3 nakamichi higashinari-ku, Osaka 537-8511
TEL 06-6972-1181
Homepage URL
Email nisino-ka@mc.pref.osaka.jp

Sponsor
Institute Osaka medical center for cancer and cardiovascular diseases
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 大阪府立成人病センター

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 17 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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2012 Year 07 Month 31 Day
Date of closure to data entry
2012 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2012 Year 01 Month 17 Day
Last modified on
2014 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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