UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039523 |
|---|---|
| Receipt number | 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 | 2021/10/08 17:18:39 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
