UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049334 |
|---|---|
| Receipt number | R000056187 |
| Scientific Title | Biomarker discovery research for malignant tumors using SCRUM-Japan GI/MONSTAR-SCREEN integrated database |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2025/06/03 12:46:45 |
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Basic information
Public title
Biomarker discovery research for malignant tumors using SCRUM-Japan GI/MONSTAR-SCREEN integrated database
Acronym
SCRUM-Japan MONSTAR-SCREEN Database Project
Scientific Title
Biomarker discovery research for malignant tumors using SCRUM-Japan GI/MONSTAR-SCREEN integrated database
Scientific Title:Acronym
SCRUM-Japan MONSTAR-SCREEN Database Project
Region
| Japan | Asia(except Japan) |
Condition
Condition
Solid Malignancies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Hematology and clinical oncology | Nephrology |
| Neurology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Ophthalmology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate molecular mechanism including therapeutic targets and therapeutic resistance through analysis of clinical and genomic information obtained from SCRUM-Japan GI/MONSTAR-SCREEN related studies; a molecular profiling platform for malignant tumors (see other related information).
In addition, by analyzing the relationship between the profile, clinicopathological factors, and clinical course using Artificial Intelligence (AI), etc., biomarkers based on the molecular biology of malignant tumors are created. The clinical course here refers to (treatment history, response rate, progression-free survival, time to treatment failure, overall survival, etc.)
Basic objectives2
Others
Basic objectives -Others
To analyze the functional and clinical significance of biomarkers such as genomic aberrations detected in malignant tumors, analyze biomarkers such as genomic aberrations detected in the main study described in Other Related Information to elucidate their clinical significance and search for new therapeutic targets.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profiles of genomic abnormalities, biomarkers, etc. in tumor tissue, blood, stool samples, images, etc.
Key secondary outcomes
Profiles of genomic abnormalities, biomarkers, etc. in tumor tissue, blood, stool samples, images, etc., and relationships with clinicopathological factors, clinical course, 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consent has not been withdrawn or refused regarding participation in the main research and secondary use of information and samples as described in other related information.
Key exclusion criteria
Those who meet any of the following criteria will be excluded from the study.
1) Data required for this study are missing.
2) Researchers deemed ineligible
Target sample size
27500
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-shi Chiba, Japan
TEL
04-7133-1111
tyoshino@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 Head and Neck Medical Oncology
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
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 26 | 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
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Integrated analysis of clinical and genomic information obtained from the following SCRUM-Japan GI/MONSTAR-SCREEN related research.
GI-SCREEN-CRC(UMIN000016343)
GI-SCREEN-nonCRC(UMIN000016344)
GOZILA(UMIN000029315)
COSMOS-CRC-01(UMIN000037765)
COSMOS-GC-01(UMIN000040148)
COSMOS-HCC-01(UMIN000041710)
COSMOS-PC-01(UMIN000040470)
COSMOS-MEL-01(UMIN000042040)
GALAXY(UMIN000039205)
MONSTAR-SCREEN(UMIN000036749)
MONSTAR-SCREEN-2(UMIN000043899)
BRANCH(UMIN000046085)
PRECISION(UMIN000042490)
ARTEMIS-PC(UMIN000043561)
SCRUM-Japan Registry(UMIN000028058)
TRIUMPH additional study(UMIN000030505)
TiFFANY additional study(JapicCTI-194796)
VOLTAGE additional study(Unregistered)
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | 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=R000056187
