UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.
Acronym	A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.
Scientific Title	A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.
Scientific Title:Acronym	A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.
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 clinical utility of liquid biopsy in cancer patients with failure or no detection of tumor tissue based comprehensive genome profiling.
Basic objectives2	Others
Basic objectives -Others	To identify the rate of gene profiling successfully by liquid biopsy in patients with failure or no detection of tumor tissue based comprehensive genome profiling.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To identify the rate of gene profiling successfully by liquid biopsy in patients with failure or no detection of tumor tissue based comprehensive genome profiling.
Key secondary outcomes	To identify the rate of targetable gene alterations detected by liquid biopsy in patients with failure or no detection of tumor tissue based comprehensive genome profiling To compare the results of gene alterations by liquid biopsy with those by companion diagnostics (CDx) To identify the rate of MSI high detected by liquid biopsy in patients with failure or no detection of tumor tissue based comprehensive genome profiling To identify the rate of patients treated with targeted therapy based on the results of liquid biopsy

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients participating, planning to participate in the prospective study to evaluate the feasibility of a comprehensive genomic profile test at the initial treatment in patients with solid tumors and its usefulness for treatment selection. Blood samples can be collected at either or both points prior to the first treatment or at the time of the progression disease. Patients who are already on second-line treatment will not be allowed to be enrolled. Patients with inadequate specimens (including insufficient specimen volume) or cases of failure for analysis by NGS testing. *Patients with lung cancer may be enrolled in the study with a specimen failure (insufficient specimen volume) or cases of failure for analysis to perform the Oncomain Dx Target Test multi-CDx system. Written consent for this study was obtained from the patients themselves.
Key exclusion criteria	-
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Yamamoto
Organization	National cancer center hospital
Division name	Department of Experimental Therapeutics
Zip code	104-0045
Address	5-1-1 Tsukiji Chuo-ku Tokyo
TEL	03-3542-2511
Email	nbryamam@ncc.go.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Yoshida
Organization	National cancer center hospital
Division name	Department of Experimental Therapeutics
Zip code	104-0045
Address	5-1-1 Tsukiji Chuo-ku Tokyo
TEL	03-3542-2511
Homepage URL
Email	tatyoshi@ncc.go.jp

Sponsor
Institute	National cancer center
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National cancer center IRB
Address	5-1-1 Tsukiji Chuo-ku Tokyo
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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 09 Month 08 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 03 Day
Date of IRB	2020 Year 08 Month 11 Day
Anticipated trial start date	2020 Year 09 Month 08 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To identify the rate of gene profiling successfully by liquid biopsy in patients with failure or no detection of tumor tissue based comprehensive genome profiling.

Management information
Registered date	2020 Year 09 Month 08 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047625