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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032831
Receipt No. R000037441
Scientific Title Trial Of Onco-panel for Geneprofiling
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/01

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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 Chikashi Ishioka
Organization Tohoku University Hospital
Division name Personalized Medicine Center
Zip code
Address 1-1 Seiryou Aoba-ku Sendai Miyagi Japan
TEL 022-717-8543
Email chikashi@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Shirota
Organization Tohoku University Hospital
Division name Personalized Medicine Center
Zip code
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)

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 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

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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
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

Other
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

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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