UMIN-CTR Clinical Trial

Basic information
Public title	Trial Of Onco-panel for Geneprofiling
Acronym	NCC Onco-panel Advanced Medical Care
Scientific Title	Trial Of Onco-panel for Geneprofiling
Scientific Title:Acronym	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	1st name Middle name Last name Noboru Yamamoto
Organization	National cancer Center Hospital
Division name	Department of Experimental Therapeutics
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	nbryamam@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Natsuko Okita
Organization	National Cancer Center Hospital
Division name	Crinical Trial Support Office
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	NCCH1616_office@ml.res.ncc.go.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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

国立がん研究センター中央病院（東京都） 国立がん研究センター東病院（千葉県） 京都大学医学部附属病院（京都府） 岡山大学病院（岡山県） 東北大学病院（宮城県） 北海道大学病院（北海道） 名古屋大学医学部附属病院（愛知県） 九州大学病院（福岡県） 慶應義塾大学病院（東京都） 神奈川県立がんセンター（神奈川県） 聖マリアンナ医科大学病院（神奈川県） 筑波大学附属病院（茨城県） 富山大学附属病院（富山県） 福井大学医学部附属病院（福井県） 名古屋市立大学病院（愛知県） 京都桂病院（京都府） 大阪赤十字病院（大阪府） 神戸市立医療センター中央市民病院（兵庫県） 和歌山県立医科大学附属病院（和歌山県） 佐賀大学医学部附属病院（佐賀県） 信州大学医学部附属病院（長野県） 兵庫県立がんセンター（兵庫県） 倉敷中央病院（岡山県） 徳島大学病院（徳島県） 国立病院機構四国がんセンター（愛媛県） 千葉県がんセンター（千葉県） 大阪医科大学附属病院（大阪府） 滋賀医科大学医学部附属病院（滋賀県） 千葉大学医学部附属病院（千葉県） 大阪市立総合医療センター（大阪府） 静岡県立総合病院（静岡県） 広島大学病院（広島県） 鳥取大学医学部附属病院（鳥取県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 09 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
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	2017 Year 12 Month 28 Day
Date of IRB	2018 Year 01 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 09 Day
Last follow-up date	2020 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 09 Day
Last modified on	2019 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036692