UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial Of Onco-panel for Geneprofiling
Title of the study (Brief title)	NCC Onco-panel Advanced Medical Care
Region	Japan

Condition
Condition	Malignant solid tumors or Cancer of unknown primary
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To estimate usefulness of multiprex genomic testing.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of actionable genomic change.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Gene
Interventions/Control_1	Multiplex genomic testing
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age over 16 years 2) ECOG PS 0 to 1 3) Pathologically diagnosed as malignant solid tumor 4) Inoperable or recurrent tumor as follows 1.Cancer of unknown primary 2.Solid tumor progressed after standard chemotherapy 5) have samples for testing 4) Written informed consent
Key exclusion criteria	none
Target sample size	350

Research contact person
Name of lead principal investigator	Chikashi Ishioka
Organization	Tohoku University Hospital
Division name	Personalized Medicine Center
Address	1-1 Seiryou Aoba-ku Sendai Miyagi Japan
TEL	022-717-8543
Email	chikashi@tohoku.ac.jp

Public contact
Name of contact person	Hidekazu Shirota
Organization	Tohoku University Hospital
Division name	Personalized Medicine Center
Address	1-1 Seiryou Aoba-ku Sendai Miyagi Japan
TEL	022-717-8543
Homepage URL
Email	hidekazu.shirota.e1@tohoku.ac.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	Japan Agency for Medical Reserch and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 01 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037441