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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040297
Receipt No. 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

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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
Email 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
Email izumo_takehiro@med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045975

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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