UMIN-CTR Clinical Trial

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
Email	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
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046239