UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061101 |
|---|---|
| Receipt number | R000069594 |
| Scientific Title | Evaluation of Methylation-Based Circulating Tumor DNA and Biomarker Associations After Curative Treatment for Resectable Solid Tumors |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/30 09:49:22 |
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Basic information
Public title
Evaluation of Methylation-Based Circulating Tumor DNA and Biomarker Associations After Curative Treatment for Resectable Solid Tumors
Acronym
Northstar-Monstar-3
Scientific Title
Evaluation of Methylation-Based Circulating Tumor DNA and Biomarker Associations After Curative Treatment for Resectable Solid Tumors
Scientific Title:Acronym
Northstar-Monstar-3
Region
| Japan |
Condition
Condition
Colorectal cancer/Ovarian cancer
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the performance of ctDNA analysis using an assay developed by BillionToOne, Inc. in predicting recurrence and prognosis in patients with solid tumors who have undergone curative-intent treatment
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between ctDNA status and clinicopathological/molecular characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between ctDNA MRD and recurrence
Key secondary outcomes
Association between ctDNA and efficacy of adjuvant therapy
Overall survival (OS)
ctDNA positivity rate
Association between ctDNA and clinicopathological/molecular characteristics, etc.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal cancer and ovarian cancer who were enrolled in the MONSTAR-SCREEN-3 trial (Cohort B) and received curative treatment
Key exclusion criteria
1.Cases with missing data required for this study.
2.Cases deemed inappropriate for enrollment in this study by the principal investigator.
3.Cases of withdrawal of consent or refusal of secondary use of specimens and/or data.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Division for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Tadayoshi |
| Middle name | |
| Last name | Hashimoto |
Organization
National Cancer Center Hospital East
Division name
Division for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
tadhashi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
BillionToOne, Inc
Department for the Promotion of Drug and Diagnostic Development,Translational Research Support Office
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@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
| 2026 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Target population:the patients who meet the selection criteria until March 31 2030 from research permit date
Management information
Registered date
| 2026 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069594
