UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060412 |
|---|---|
| Receipt number | R000068097 |
| Scientific Title | Integrated Analysis of Radiomics and Molecular Profiling in malignant tumors |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/20 16:52:01 |
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Basic information
Public title
Integrated Analysis of Radiomics and Molecular Profiling in malignant tumors
Acronym
SCRUM-MONSTAR Radiomics Substudy
Scientific Title
Integrated Analysis of Radiomics and Molecular Profiling in malignant tumors
Scientific Title:Acronym
SCRUM-MONSTAR Radiomics Substudy
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Vascular surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Urology |
| Oral surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
By analyzing CT/MRI and other radiological image data obtained from malignant tumor patients enrolled in studies collecting such data (see below) within the SCRUM-MONSTAR-related research-a molecular profiling platform for malignant tumors-we elucidate the radiological image profiles in malignant tumor patients. Furthermore, by analyzing the relationship between the radiological imaging profile and clinical information obtained from the SCRUM-MONSTAR-related research-including clinical pathological factors, clinical course (treatment history, response rate, progression-free survival, treatment success period, overall survival, etc.)-and molecular profiles (gene abnormalities, gene expression, tumor microenvironment, etc.), we will create a biomarker that integrates the radiological imaging profile.
UMIN000039205-GALAXY Trial: Registry Study for Curatively Resectable Colorectal Cancer
UMIN000053975-MONSTARSCREEN-3: Multicenter Collaborative Study Aiming to Elucidate Spatiotemporal Molecular Profiles in Malignant Tumor Patients
jRCTs031220342-ENSEMBLE: Multicenter Randomized Phase III Trial Comparing Short-Course Radiotherapy with CAPOX vs. Short-Course Radiotherapy with CAPOXIRI as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
--IDEAL-TRJapan: International Multicenter Observational Study to Identify Early Clinical Features Indicating True Response at Reassessment Following TNT for Locally Advanced Rectal Cancer
Basic objectives2
Others
Basic objectives -Others
By analyzing the relationship between radiological imaging profiles and clinical information including clinical pathological factors, clinical course (treatment history, response rate, progression free survival, treatment success period, overall survival, etc.) and molecular profiles (genetic abnormalities, gene expression, tumor microenvironment, etc.) obtained from SCRUM MONSTAR related studies, we will create integrated biomarkers incorporating radiological imaging profiles.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiographic Profiles in Solid Cancer Patients
Key secondary outcomes
Correlation between Radiological Imaging Profiles and Clinical Information (including Clinical Pathological Factors and Clinical Course) and Molecular Profiles in Solid Cancer Patients
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).Regarding participation in the main study and secondary use of information, consent has not been withdrawn or refused for that study.
2).Radiological imaging data is being collected in the main study.
Key exclusion criteria
The researcher is deemed unqualified.
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Bandou |
Organization
National Cancer Center Hospital East
Division name
Department of Advancing Pharmaceutical Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
hbando@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Fujisawa |
Organization
National Cancer Center Hospital East
Division name
Department of Advancing Pharmaceutical Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
tafujisa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
LPIXEL Inc.
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, 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
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 20 | 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
| 2016 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
SCRUM-MONSTAR-related studies collecting radiological image data (Abbreviation/Full Name/ID/Study Number/Approximate Number of Cases/Registration Period)
GALAXY Trial/Registry study targeting colorectal cancer amenable to curative surgery/UMIN000039205/2019-206/5000 cases/Jan. 9, 2020 - Mar. 31, 2023
MONSTAR-SCREEN-3/Multicenter Collaborative Study Aiming to Elucidate Spatiotemporal Molecular Profiles in Malignant Tumor Patients/UMIN000053975/2023-354/3,200 Cases/Feb. 27, 2024 - Mar. 31, 2027
ENSEMBLE/Multicenter Randomized Phase III Trial Comparing Short-Course Radiotherapy with CAPOX vs. Short-Course Radiotherapy with CAPOXIRI as Neoadjuvant Therapy for Locally Advanced Rectal Cancer/jRCTs031220342 CTA-E22003/608/2022.10.31-2026.12.31
IDEAL-TR Japan/International Multicenter Observational Study to Identify Early Clinical Features Indicating True Response at Reassessment Following TNT in Locally Advanced Rectal Cancer/-/2024-212/160/2024.11.19-2026.3.31
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068097
