UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058648 |
|---|---|
| Receipt number | R000061817 |
| Scientific Title | Real world use of biomarker testing using blood-based liquid biopsy in Japan |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/10/06 15:57:13 |
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Basic information
Public title
Real world use of biomarker testing using blood-based liquid biopsy in Japan
Acronym
Real world use of biomarker testing using blood-based liquid biopsy in Japan
Scientific Title
Real world use of biomarker testing using blood-based liquid biopsy in Japan
Scientific Title:Acronym
Real world use of biomarker testing using blood-based liquid biopsy in Japan
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Nephrology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To describe treatment and testing patterns, as well as clinical characteristics of patients who underwent biomarker testing using liquid biopsy in Japan.
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study using C-CAT (Center for Cancer Genomics and Advanced Therapeutics)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment pattern before and after CGP (cancer genomic profiling),
Biomarker testing pattern
Key secondary outcomes
Specific genomic status (EGFR, KRAS, MSI, TMB or other actionable mutations)
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have at least 1 record for a liquid biopsy test (FoundationOne Liquid or Guardant360).
Key exclusion criteria
There are no exclusion criteria for this study.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Yasuoka |
Organization
MSD K.K
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE 1-13-12 Kudan-Kita, Chiyoda-ku, Tokyo
TEL
03-6272-1000
shotaro.yasuoka@merck.com
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Tetsuka |
Organization
MSD K.K
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE 1-13-12 Kudan-Kita, Chiyoda-ku, Tokyo
TEL
03-6272-1000
Homepage URL
jumpei.tetsuka@merck.com
Sponsor or person
Institute
MSD K.K
Institute
Department
Personal name
Funding Source
Organization
MSD K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Fujikeikai Kitamachi Clinic Ethics Review Committee
Address
1-1-3 Kichijoji-Kitamachi, Musashino-shi, Tokyo
Tel
0422-22-8151
chi-pr-ec-kitamachi@cmicgroup.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
| 2025 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cas.70174
Number of participants that the trial has enrolled
7461
Results
This study analyzed 7461 cases from the C-CAT database to assess real-world use of FoundationOne Liquid testing. Pancreatic, prostate, and biliary cancers were most common. After MTB review, 5.8% received new treatments, mainly targeted therapy and chemotherapy. KRAS and BRCA2 mutations were frequent, especially in pancreatic and bowel cancers. The utility of CGP-guided treatment varied by cancer type.
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 26 | Day |
Baseline Characteristics
The average age was 65.1 years, with 58.8% male participants. ECOG performance status was 0 in 51.3% and 1 in 39.3%. Metastatic disease was present in 86.8% of cases. Smoking history was reported in 45.3%, and 66.5% had a family history of cancer.
Participant flow
A total of 7461 CGP test records were included from the C-CAT database. Most tests were conducted after initiation of second-line therapy. Post-MTB treatment was initiated in 738 cases (9.9%).
Adverse events
N/A
Outcome measures
Primary outcomes included treatment patterns before and after testing, rate of new treatment initiation, and mutation frequencies. Exploratory analyses examined associations between specific genomic alterations and treatment decisions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 25 | Day |
Other
Other related information
database study
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061817
