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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039523
Receipt No. R000045046
Scientific Title A multicenter retrospective study of Oncomine Dx Target Test Multi-CDx system for genetic profiling of non-small cell lung cancer (DETECT-LC)(WJOG13019L)
Date of disclosure of the study information 2020/02/18
Last modified on 2020/08/19

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Basic information
Public title A multicenter retrospective study of Oncomine Dx Target Test Multi-CDx system for genetic profiling of non-small cell lung cancer
(DETECT-LC)(WJOG13019L)
Acronym A multicenter retrospective study of Oncomine Dx Target Test Multi-CDx system
Scientific Title A multicenter retrospective study of Oncomine Dx Target Test Multi-CDx system for genetic profiling of non-small cell lung cancer
(DETECT-LC)(WJOG13019L)
Scientific Title:Acronym A multicenter retrospective study of Oncomine Dx Target Test Multi-CDx system
Region
Japan

Condition
Condition Non-small cell lung cancer (NSCLC)
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this retrospective study is to investigate the usefulness of Oncomine Dx Target Test Multi-CDx system as a companion diagnostics system for genetic profiling of NSCLC.
Basic objectives2 Others
Basic objectives -Others Success rate of gene mutation measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of gene mutation measurement (EGFR gene mutation, ALK gene rearrangement, ROS1 gene rearrangement, BRAF gene mutation) by Oncomine Dx Target Test Multi-CDx system
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 1.Histologically or cytologically confirmed NSCLC
2.Measured 46 genes by Oncomine Dx Target Test Multi-CDx system between June 1, 2019 and January 31, 2020.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Otsubo
Organization Kitakyushu Municipal Medical Center
Division name Department of Respiratory Medicine
Zip code 802-0077
Address 2-1-1-, Basyaku, Kokurakita-Ku, Kitakyushu city, Fukuoka, Japan
TEL 093-541-1831
Email ootsubo@kokyu.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code 556-0016
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization ThermoFisher Scientific Life Technologies Japan Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitakyushu Municipal Medical Center
Address 2-1-1-, Basyaku, Kokurakita-Ku, Kitakyushu city, Fukuoka, Japan
Tel 093-541-1831
Email ootsubo@kokyu.kyushu-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
2020 Year 02 Month 18 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 533
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
2020 Year 02 Month 11 Day
Date of IRB
2020 Year 02 Month 17 Day
Anticipated trial start date
2020 Year 04 Month 20 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All the driver genes (EGFR, ALK, ROS1, BRAF) and individual success rate in the measurement of Oncomine Dx Target Test Multi-CDx system will be counted.

Management information
Registered date
2020 Year 02 Month 18 Day
Last modified on
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045046

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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