UMIN-CTR Clinical Trial

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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