UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012403 |
|---|---|
| Receipt number | R000014451 |
| Scientific Title | Retrospective study for investigation of proteinuria generation and anti-proteinuria effect of RAS inhibitor in non-small cell lung cancer patients who received bevacizumab chemotherapy(NJLCG1303) |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2024/06/05 08:24:38 |
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Basic information
Public title
Retrospective study for investigation of proteinuria generation and anti-proteinuria effect of RAS inhibitor in non-small cell lung cancer patients who received bevacizumab chemotherapy(NJLCG1303)
Acronym
NJLCG1303
Scientific Title
Retrospective study for investigation of proteinuria generation and anti-proteinuria effect of RAS inhibitor in non-small cell lung cancer patients who received bevacizumab chemotherapy(NJLCG1303)
Scientific Title:Acronym
NJLCG1303
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe and clarify situation of proteinuria generation and anti-proteinuria effect of RAS inhibitor in non-small cell lung cancer patients who received bevacizumab chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proteinuria(1+ or severer dipstick and/or 0.15g/gCr or severer UPCR)
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
Non-small cell lung cancer patients who received bevacizumab chemotherapy
Key exclusion criteria
Patients with diabetes during treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Morikawa |
Organization
Iwate Medical University
Division name
Collagen disease, Allergy and Respiratory Medicine
Zip code
Address
19-1 Uchimaru, Morioka-shi, Iwate
TEL
019-651-5111
carcinoma@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sato Junya |
Organization
Iwate Medical University
Division name
Department of Pharmacy
Zip code
Address
19-1 Uchimaru, Morioka-shi, Iwate
TEL
019-651-5111
Homepage URL
junya02377@nifty.com
Sponsor or person
Institute
North Japan Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
北日本肺癌臨床研究グループ
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2013 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014451
