UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053975 |
|---|---|
| Receipt number | R000061608 |
| Scientific Title | Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor |
| Date of disclosure of the study information | 2024/03/27 |
| Last modified on | 2024/03/26 19:48:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor
Acronym
SCRUM-Japan MONSTAR-SCREEN-3
Scientific Title
Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor
Scientific Title:Acronym
SCRUM-Japan MONSTAR-SCREEN-3
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 | Chest surgery | Breast 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
For patients with malignant tumors, molecular profiling including spatial transcriptome analysis using tumor tissue over time can elucidate the molecular pathology of tumors, including spatiotemporal heterogeneity.
In addition, digital imaging of pathological specimens such as H&E staining and imaging profiling of radiographic diagnostic images such as CT/MRI are also being considered. By analyzing the relationship between molecular profiles or image profiles and clinical pathological factors and clinical course using artificial intelligence (AI), etc., biomarkers reflecting the molecular biological essence of malignant tumors can be created.
Basic objectives2
Others
Basic objectives -Others
Evaluate the association between molecular profiles such as genetic abnormalities and RNA expression profiles in tumor tissues and ctDNA, profiles of biomarkers like TMB, LOH, MSI, etc., MRD profiles, germline genetic abnormalities profiles, profiles of gut and oral microbiota, as well as image profiles like pathology and radiographic images, with clinical pathological factors and clinical course.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
i. Molecular profiles such as gene abnormalities, RNA expression profiles, and profiles of biomarkers such as TMB, LOH, MSI, MRD, profiles of genetic abnormalities in germ cell lines, and profiles of intestinal bacterial flora in tumor tissue and ctNA.
ii.Image profiles such as pathological image profiles and radiographic image profiles.
Key secondary outcomes
i. Molecular profiles such as gene abnormalities, RNA expression profiles, and profiles of biomarkers such as TMB, LOH, MSI, profiles of MRD, profiles of genetic abnormalities in germ cell lines, and profiles of intestinal bacterial flora in tumor tissue and ctNA, and their relationship with clinical pathological factors and clinical course.
ii. Image profiles such as pathological image profiles and radiographic image profiles, and their relationship with clinical pathological factors and clinical course.
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
1.18 or older when consent is obtained.
2. Pathologically diagnosed with malignant tumor.
3. Obtained written consent from the patient for this study.
4.One of the following applies:
Cohort A: Diagnosed with progressive inoperable malignant solid tumor and meets either of the following:
(i) Before the first drug therapy.
(ii)Preceding drug therapy has ended or is expected to end, and designated targeted therapy is planned as the next treatment.
Cohort B: Diagnosed with malignant solid tumor, and curative resection or curative chemotherapy, radiation therapy, or chemoradiotherapy is planned.
Cohort C: Diagnosed with hematopoietic malignant tumor and meets either of the following:
(i) Before the first drug therapy.
(ii)Preceding drug therapy has ended or is expected to end, and the next treatment is planned.
5.ECOG PS is 0 or 1.
6.Expected to survive for 12 weeks or more from the registration date.
7. Residual tissue that can be submitted for this study exists, or it is planned to collect tissue and submit residual tissue.
8.Willing to receive research-based treatment according to the analysis results in this study.
Key exclusion criteria
1.Has a history of allogeneic hematopoietic stem cell transplantation or organ transplantation (Cohorts A and B).
2.Is pregnant.
3.Has a history of or concurrent malignancy other than the target malignancy within 3 years prior to registration.
4.Has a severe comorbidity. (e.g., uncontrolled diabetes, infection, interstitial pneumonia, or pulmonary fibrosis with symptoms)
5.The attending physician determines that registration in this study is inappropriate.
Target sample size
3200
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 | 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
SCRUM Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
iTMS Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 27 | 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
| 2024 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we perform longitudinal molecular profiling, including spatial transcriptome analysis using tumor tissues, to elucidate the molecular pathology of tumors, including their spatiotemporal heterogeneity. Additionally, we consider image profiling of digital pathologies, such as H&E staining of pathological specimens, and radiodiagnostic images like CT/MRI. By analyzing the correlation between these molecular and image profiles with clinicopathological factors and clinical course (treatment history, response rate, progression-free survival, treatment success period, overall survival, etc.) using Artificial Intelligence (AI), we aim to create biomarkers that reflect the molecular biological essence of malignant tumors.
Management information
Registered date
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061608
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
