UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030618 |
|---|---|
| Receipt number | 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 19:34:51 |
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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
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
hatanaka-nobuyoshi@linical.co.jp
Sponsor or person
Institute
AstraZeneca K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034960
