UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040297 |
|---|---|
| Receipt number | R000045975 |
| Scientific Title | A retrospective study on driver genetic testing using the Oncomine Dx Target Test in clinical practice |
| Date of disclosure of the study information | 2020/05/02 |
| Last modified on | 2020/05/02 19:18:59 |
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Basic information
Public title
A retrospective study on driver genetic testing using the Oncomine Dx Target Test in clinical practice
Acronym
J-ONCOMINE
Scientific Title
A retrospective study on driver genetic testing using the Oncomine Dx Target Test in clinical practice
Scientific Title:Acronym
J-ONCOMINE
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Oncomine Dx Target Test for the case using the multi-CDx system, examine retrospectively the procedure contents of sample collection and case background
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gender, age
Chest image findings
Stage
Treatment method
Tumor size
Tumor location
Biopsy method
Device used during biopsy, anesthesia method
Presence or absence of virtual endoscope and findings
EBUS (Ultrasound in the bronchial cavity) presence / absence
Inspection time
complications
Results of Cobas EGFR mutation detection kit v2.0
Cell/tissue diagnosis results
Number of tissue samples
Tissue sampling size
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
Lung cancer patients who have been genetically analyzed by the Oncomine Dx Target Test
Key exclusion criteria
Those who refused to participate in the study by opt-out
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
150-8935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3400-1311
izumo_takehiro@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
150-8935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3400-1311
Homepage URL
izumo_takehiro@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Medical Center
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
Japanese Red Cross Medical Center
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
Tel
03-3400-1311
izumo_takehiro@med.jrc.or.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 | 05 | Month | 02 | 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
27
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045975
