UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040506 |
|---|---|
| Receipt number | R000046239 |
| Scientific Title | Cancer gene panel of plasma DNA in patients with solid tumor |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/25 11:07:39 |
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Basic information
Public title
Cancer gene panel of plasma DNA in patients with solid tumor
Acronym
Cancer gene panel of plasma DNA in patients with solid tumor
Scientific Title
Cancer gene panel of plasma DNA in patients with solid tumor
Scientific Title:Acronym
Cancer gene panel of plasma DNA in patients with solid tumor
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the gene analysis of plasma DNA by NGS in patients with metastatic solid tumor
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of somatic gene alterations in plasma DNA
Key secondary outcomes
Detection rate of somatic gene alterations in plasma DNA by cancer type.
Detection rate of somatic gene alterations in plasma DNA by gene.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patinets with metastatic solic tumor
2) Age >= 20 years old
3) Patients with tumor harboring gene alteration
4) Written informed consent
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Urakami |
Organization
Shizuoka Cancer Center Research Institute
Division name
Cancer Diagnostics Research Division
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
TEL
0559895222
k.urakami@scchr.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Division of Genetic Medicine Promotion
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
TEL
0559895222
Homepage URL
h.kenmotsu@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center IRB
Address
1007 Shimonagakubo, Nagaizumi-cho
Tel
0559895222
rinsho_office@scchr.jp
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
| 2020 | Year | 05 | Month | 26 | 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
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
20 mL blood sample will be obtained from patiets emrolled into this study.
Management information
Registered date
| 2020 | Year | 05 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046239
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| Registered date | File name |
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