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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012403
Receipt No. 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 2015/06/05

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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
Email 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
Email junya02377@nifty.com

Sponsor
Institute North Japan Lung Cancer Study Group
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
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
2015 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014451

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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