UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049151 |
|---|---|
| Receipt number | R000055984 |
| Scientific Title | ctDNA/RNA genomic profiling in rare cancers with gene rearrangements |
| Date of disclosure of the study information | 2022/10/08 |
| Last modified on | 2025/10/10 01:19:44 |
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Basic information
Public title
ctDNA/RNA genomic profiling in rare cancers with gene rearrangements
Acronym
MASTER KEY Liquid
Scientific Title
ctDNA/RNA genomic profiling in rare cancers with gene rearrangements
Scientific Title:Acronym
MASTER KEY Liquid
Region
| Japan |
Condition
Condition
Rare solid tumors with gene rearrangements
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze and monitor the cfDNA/RNA through each patients' treatment course
Basic objectives2
Others
Basic objectives -Others
Biomarker exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate, types, and trend of detected gene alterations through the treatment course
Key secondary outcomes
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
7 yrs or older.
Diagnosed as a rare solid cancer with a gene rearrangement.
Pharmacotherapy treatment is planned.
Has results of tissue tumor biomarker test results.
Written informed consent.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Yonemori |
Organization
National Cancer Center Hospital
Division name
Department of Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
kyonemor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Okuma |
Organization
National Cancer Center Hospital
Division name
Department of Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
hsumiyos@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Independent Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
0335422511
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
合同会社H.U.グループ中央研究所
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
40
Results
unpublished
Results date posted
| 2025 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unpublished
Participant flow
unpublished
Adverse events
unpublished
Outcome measures
unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055984
