UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056873 |
|---|---|
| Receipt number | R000064982 |
| Scientific Title | Integrative Spatiotemporal Multi-omics and Single-cell Analysis of Circulating Tumor Cells for Development of Novel Metastasis Control Strategies in Solid Malignancies |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/06/03 11:39:34 |
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Basic information
Public title
Integrative Spatiotemporal Multi-omics and Single-cell Analysis of Circulating Tumor Cells for Development of Novel Metastasis Control Strategies in Solid Malignancies
Acronym
MONSTAR-CTC
Scientific Title
Integrative Spatiotemporal Multi-omics and Single-cell Analysis of Circulating Tumor Cells for Development of Novel Metastasis Control Strategies in Solid Malignancies
Scientific Title:Acronym
MONSTAR-CTC
Region
| Japan |
Condition
Condition
Malignant solid tumors
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Nephrology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To implement circulating tumor cell (CTC) analysis as a high-precision liquid biopsy platform for therapeutic target identification and to elucidate metastatic mechanisms through CTC single-cell analysis, ultimately developing novel anti-metastatic therapeutics.
Basic objectives2
Others
Basic objectives -Others
This is a correlative study within the MONSTAR-SCREEN-3 trial, a multi-institutional molecular profiling project, prospectively evaluating CTCs in patients with advanced solid tumors. The study includes CTC isolation, immunofluorescence-based expression profiling, single-cell RNA analysis, and basic drug discovery research. This observational study will evaluate associations between CTC analyses and clinicopathological factors, treatment outcomes, and multi-omics profiling data from the MONSTAR-SCREEN-3 study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between CTC molecular profiling and treatment outcomes, including prognostic implications
Key secondary outcomes
Association between CTC molecular profiles and multi-omics data from MONSTAR-SCREEN-3
1.Correlation of CTC molecular profiles with clinicopathological factors, including:
2.Overall survival
*Progression-free survival
*Concordance between tumor tissue and CTC RNA profiles
3.Assessment of anti-metastatic therapeutic targets through CTC analysis
4.Evaluation of Adherent-to-Suspension Transition (AST) factors
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
1.Age 18 years or older at the registration
2.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
3.Enrolled in MONSTAR-SCREEN-3 study without withdrawal of consent or refusal for secondary use of information and samples
4.Written informed consent
Key exclusion criteria
1.Active serious infectious disease
2.Life expectancy of less than a few weeks
3.Females during pregnancy or may be pregnant
4.Presence of significant cardiovascular disease, severe hepatic dysfunction, severe renal dysfunction, or poorly controlled diabetes mellitus
5.Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
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
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
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
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
YONSEI University,Seoul,Korea, iTMS Co., Ltd.
Name of secondary funder(s)
National Research Funding of Korea
SCRUM Japan
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
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
| 2025 | Year | 02 | Month | 01 | 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
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 16 | 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
To implement circulating tumor cell (CTC) analysis as a high-precision liquid biopsy platform for therapeutic target identification and to elucidate metastatic mechanisms through CTC single-cell analysis, ultimately developing novel anti-metastatic therapeutics.
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064982
