UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050424 |
|---|---|
| Receipt number | R000057366 |
| Scientific Title | A retrospective analysis on the lung cancer specimens for Oncomine Dx Target Test in Keio University Hospital |
| Date of disclosure of the study information | 2023/02/25 |
| Last modified on | 2023/02/20 07:33:58 |
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Basic information
Public title
A retrospective analysis on the lung cancer specimens for Oncomine Dx Target Test in Keio University Hospital
Acronym
A retrospective analysis on the lung cancer specimens for ODxTT in Keio University Hospital
Scientific Title
A retrospective analysis on the lung cancer specimens for Oncomine Dx Target Test in Keio University Hospital
Scientific Title:Acronym
A retrospective analysis on the lung cancer specimens for ODxTT in Keio University Hospital
Region
| Japan | Asia(except Japan) |
Condition
Condition
Non-small cell lung cancer (NSCLC)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the actual status of the Oncomine Dx Target Test Multi-CDx test at Keio University Hospital and examine the feasibility of the test.
Basic objectives2
Others
Basic objectives -Others
Success rate of gene mutation detection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of driver gene mutation detection in the 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. Cases with a confirmed diagnosis of histologically unresectable advanced or recurrent non-small cell lung cancer
2. Cases with ODxTT testing performed between May 2020 and October 2022
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Kawada |
Organization
Keio University School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
ichirok@a3.keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Terai |
Organization
Clinical Lung Cancer Genomics Research Group
Division name
Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Homepage URL
hidekiterai@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3793
ichirok@a3.keio.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
CATHOLIC UNIVERSITY OF KOREA
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 25 | 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
500
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 | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare mutation detection rates between ODxTT and the EGFR clamp method for EGFR mutation detection rates.
Management information
Registered date
| 2023 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057366
