UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007081 |
|---|---|
| Receipt number | 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 17:23:57 |
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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
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
nisino-ka@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka medical center for cancer and cardiovascular diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008337
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| Registered date | File name |
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