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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033647
Receipt No. R000038129
Official scientific title of the study Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/08

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Basic information
Official scientific title of the study Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors
Title of the study (Brief title) Todai OncoPanel (Advanced Medical Care Category B)
Region
Japan

Condition
Condition Malignant solid tumors (including both carcinoma and sarcoma)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To estimate usefulness of a multiplex genomic testing "Todai OncoPanel"
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of actionable genomic alterations (both therapeutically and diagnostically)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically diagnosed as malignant tumors (either carcinoma or sarcoma) (except for hematopoietic malingancies)
2) Considered to be incurable due to unresectable or recurrent condition
3) Already treated by standard therapies
4) Genomic testing is considered to be useful for decision of a therapeutic option
5) Performance Status: 0 or 1
6) Tumor sample is sufficiently available for the testing
7) Written informed consent
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator Katsutoshi Oda
Organization The University of Tokyo Hospital
Division name Department of Obstetrics and Gynecology
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email katsutoshi-tky@umin.ac.jp

Public contact
Name of contact person Shiori Toyomaru
Organization The University of Tokyo Hospital
Division name Medical Division
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL http://todaioncopanel.umin.jp/
Email IjiAll@adm.h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
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

Other related organizations
Co-sponsor Sysmex CO., LTD., RIKEN GENESIS CO., LTD., Xcoo CO.LTD.
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 08 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 08 Month 06 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038129

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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