UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041722 |
|---|---|
| Receipt number | 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 | 2021/03/31 18:48:40 |
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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
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
tatyoshi@ncc.go.jp
Sponsor or person
Institute
National cancer center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047625
