UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032831 |
|---|---|
| Receipt number | 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 14:58:04 |
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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
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
hidekazu.shirota.e1@tohoku.ac.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
