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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035180
Receipt No. R000040096
Scientific Title Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC
Date of disclosure of the study information 2018/12/08
Last modified on 2019/06/09

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Basic information
Public title Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC
Acronym NLCTG1501-BM
Scientific Title Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC
Scientific Title:Acronym NLCTG1501-BM
Region
Japan

Condition
Condition ALK-positive non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC.
Basic objectives2 Others
Basic objectives -Others To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC, liquid biopsy will be performed.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC.
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 According to NLCTG1501
Key exclusion criteria According to NLCTG1501
Target sample size 11

Research contact person
Name of lead principal investigator
1st name Toshoaki
Middle name
Last name Kikuchi
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Respiratory Medicine and Infectious Diseases
Zip code 9518510
Address 1-757 Asahimachidori, Chuouku, Niigata, Japan
TEL 025-368-9325
Email kikuchi@med.niigta-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Watanabe
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Respiratory Medicine and Infectious Diseases
Zip code 9518510
Address 1-757 Asahimachidori, Chuouku, Niigata, Japan
TEL 025-368-9325
Homepage URL
Email satoshi7@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata 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 Institutional Review Board of the Niigata University
Address 1-754 Asahimachidori, Chuouku, Niigata, Japan
Tel 025-2272625
Email sanonao@adm.niigata-u.ac.jp

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
2018 Year 12 Month 08 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 12
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 No longer recruiting
Date of protocol fixation
2015 Year 10 Month 15 Day
Date of IRB
2015 Year 11 Month 16 Day
Anticipated trial start date
2015 Year 10 Month 15 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate tumor DNA and RNA from plasma of patients treated in NLCTG1501 trial.

Management information
Registered date
2018 Year 12 Month 08 Day
Last modified on
2019 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040096

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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