UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062142 |
|---|---|
| Receipt number | R000071114 |
| Scientific Title | Evaluation of the current impact and utility of cancer comprehensive genomic profiling in Japan |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/06 11:47:50 |
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Basic information
Public title
Evaluation of the current impact and utility of cancer genomic testing in Japan
Acronym
Impact of cancer genomic testing in Japan
Scientific Title
Evaluation of the current impact and utility of cancer comprehensive genomic profiling in Japan
Scientific Title:Acronym
Evaluation of the current impact and utility of CGP in Japan
Region
| Japan |
Condition
Condition
Solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. To evaluate overall survival (OS) in patients who received molecularly targeted therapy (MBRT) recommended by the Expert Panel (EP) after comprehensive genomic profiling (CGP) testing, compared to patients who received standard of care (SOC) treatment.
2. To assess the post-CGP Cox proportional hazard ratio after stratifying patients by the timing of CGP testing (early vs. late in disease course).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Overall survival (OS) in patients who received molecularly targeted therapy (MBRT) recommended by the Expert Panel (EP) after comprehensive genomic profiling (CGP) testing, compared to patients who received standard of care (SOC) treatment.
2. Post-CGP Cox proportional hazard ratio after stratifying patients by the timing of CGP testing (early vs. late in disease 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those registered in C-CAT between June 2019 and September 2025, and who, at the time of receiving cancer gene panel testing provided informed consent. The study will target the top 10 cancer types in the C-CAT database, as well as cancer types for which clinical trials are ongoing with entry criteria based on the presence or absence of gene mutations.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded from the study:
1. Patients whose diagnostic information is missing
2. Patients missing any of the key data required for analysis
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Masachika |
| Middle name | |
| Last name | Ikegami |
Organization
National Cancer Center Research Institute
Division name
Bioinformatics
Zip code
104-0045
Address
Tokyo, Chuo-ku Tsukiji 5-1-1
TEL
(03)3542-2511
maikegam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Victoria Serelli |
| Middle name | |
| Last name | Lee |
Organization
Eli Lilly Japan KK
Division name
Japan Drug Development and Medical Affairs
Zip code
6510086
Address
Kobe, Chuo-ku Isogamidori 5-1-28 LILLY PLAZA ONE BLDG
TEL
078-242-8632
Homepage URL
lee_victoria@lilly.com
Sponsor or person
Institute
National Cancer Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research Institute
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Heishinkai Medical Corporation OPHAC
Address
Osaka, Yodogawa-ku, Miyahara 4-1-29
Tel
06-6395-9000
lee_victoria@lilly.com
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
| 2026 | Year | 07 | Month | 06 | 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
| 2026 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Observational Study
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071114
