UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041722
Receipt No. R000047625
Scientific Title A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.
Date of disclosure of the study information 2020/09/08
Last modified on 2020/09/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
2020 Year 09 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.