UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030618
Receipt No. R000034960
Scientific Title Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Date of disclosure of the study information 2017/12/28
Last modified on 2019/02/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Acronym BRAVE-Study
Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Scientific Title Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Scientific Title:Acronym BRAVE-Study
Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Region
Japan

Condition
Condition non-squamous
Non-small-cell lung carcinoma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out if necessary and sufficient biomarker testing* is conducted before starting the 1st line therapy in the advanced/metastatic non-squamous NSCLC patients
Basic objectives2 Others
Basic objectives -Others 1.To investigate the biomarker testing status in real world setting
2.To investigate the pattern of biomarker tests (types of testing and order)
3.To investigate the time required from definitive diagnosis until the start of treatment
4.To investigate the first-line treatment selected
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of patients who could select first-line treatment based on the results of biomarker testing
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 1.Patients with histologically confirmed non-squamous NSCLC who initiated first-line therapy between August 1, 2017 and December 31, 2017
2.Participants with locally advanced or metastatic non-squamous NSCLC at the diagnosis who were not indicated for radical surgery or radiotherapy
3.Patients with ECOG PS of 0-1 at the time of diagnosis
4.Patients who provided consent to participate in this study (However, in case of death or lost to follow-up, instructions from the Institutional Review Board at each site should be followed)
Key exclusion criteria 1.Patients with postoperative recurrence
2.Patients enrolled in clinical trials of an unapproved drug as first-line therapy for advanced NSCLC
3.Patients otherwise considered unsuitable to participate in this study by investigators at study sites
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Matsubara
Organization AstraZeneca K.K.
Division name Medical, Oncology, Therapeutic Area
Zip code
Address Marunouchi Trust Tower 1-8-3, Marunouchi, Chiyoda-ku,Tokyo, Japan
TEL +81-3-6268-2650
Email Mari.Matsubara@astrazeneca.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyoshi Hatanaka
Organization Linical Co.,Ltd.
Division name Contract Medical Affairs Clinical Trial Division
Zip code
Address 1-6-1 Miyahara, Yodogawa-ku,Osakashi, Osaka,Japan
TEL +81-6-6150-2210
Homepage URL
Email hatanaka-nobuyoshi@linical.co.jp

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Linical Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 D5160R00029
Org. issuing International ID_1 AstraZeneca K.K.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛知県がんセンター中央病院(愛知県)、北海道大学病院(北海道)、関西医科大学附属枚方病院(大阪府)、地方独立行政法人大阪府立病院機構大阪国際がんセンター(大阪府)、独立行政法人国立病院機構刀根山病院(大阪府)、埼玉県立がんセンター(埼玉県)、北九州市立医療センター(福岡県)、新潟県立がんセンター新潟病院(新潟県)、社会福祉法人 恩賜財団 済生会熊本病院(熊本県)、神奈川県立病院機構 神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 28 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2018 Year 05 Month 21 Day
Date of closure to data entry
2018 Year 06 Month 14 Day
Date trial data considered complete
2018 Year 08 Month 02 Day
Date analysis concluded
2019 Year 01 Month 16 Day

Other
Other related information Study Design
Japanese, multicenter, retrospective, observational study

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.