UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043899 |
|---|---|
| Receipt number | R000050019 |
| Scientific Title | A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2024/04/15 09:19:52 |
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Basic information
Public title
A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors
Acronym
SCRUM-Japan MONSTAR-SCREEN-2
Scientific Title
A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors
Scientific Title:Acronym
SCRUM-Japan MONSTAR-SCREEN-2
Region
| Japan |
Condition
Condition
Advanced Solid Malignancies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Urology |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To perform whole exome sequencing (WES), whole transcriptome sequencing (WTS), immunohistochemistry (IHC), etc. on tumor tissue in patients with advanced solid malignant tumors, and to perform WES, Sanger sequence, Multiplex Ligation-dependent Probe Amplification (MLPA), etc. on peripheral blood mononuclear cells, and elucidate molecular abnormalities in a multi-layered manner. By also performing WES/WTS on circulating tumor nucleic acid (ctNA) before and after drug therapy, the spatial-temporal heterogeneity will also be evaluated comprehensively, and also, by performing WES/WTS/IHC upon progression after drug therapy (including during systemic therapy and at the completion of planned treatment), the mechanism of treatment resistance will be evaluated. In addition, intestinal microbiota analysis using fecal specimens will be performed before and after drug therapy to evaluate the intestinal microbiota profile. Furthermore, by performing plasma proteomics before and after drug therapy on trace amounts of plasma proteins in the blood, we will also analyze dynamic changes in biological signals before and after treatment. Also, by using artificial intelligence (AI) and the like to analyze the relationship between that profile and clinical pathological factors, clinical course (treatment history, response rate, progression-free survival, duration of successful treatment, overall survival, etc.) and the like, biomarkers that reflect the biomolecular essence of solid malignant tumors will be created.
Basic objectives2
Others
Basic objectives -Others
This research is observational research to evaluate the profiles of genetic abnormalities, RNA expression, and biomarkers in tumor tissue and ctNA and the profiles of germline genetic abnormalities in blood evaluated with germline profile, gut microbiota profile, plasma protein profile and the results of protein expression in tumor tissue evaluated with tissue genome profiling and IHC, and the like, in terms of their relationship with clinical pathological factors, clinical course, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue.
ii. Profiles of gene abnormalities, RNA expression, biomarkers, etc. in ctNA.
iii. Profile of germline gene abnormalities in blood etc.
iv. Gut microbiota profile.
v. Plasma protein profile.
Key secondary outcomes
i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue
And clinical pathological factors, association with clinical course.
ii. Relationship between profile of gene abnormality, RNA expression, biomarker, etc. in ctNA and clinical pathological factors, clinical course.
iii. Relationship between Germline Gene Abnormality Profiles in Blood etc and Clinicopathological Factors and Clinical Course.
iv. Relationship between gut microbiota profile, clinicopathological factors, and clinical course.
v. Associations between plasma protein profiles, clinicopathological 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.At least 18 years old when informed consent is obtained.
2.Histopathologically diagnosed as having advanced solid malignancy.
3.No curative treatment is available.
4.Consent has been obtained in writing from the patient regarding participation in this research.
5.Satisfiesb i, ii or iii below.
i.Before undergoing first-line systemic therapy.
ii.The disease progresses during systemic therapy and the patient is scheduled to undergo designated targeted therapy as the subsequent treatment.
iii. Have a specific genetic abnormality
6.Eastern Cooperative Oncology Group performance status is 0 or 1.
7.Can submit a formalin fixed paraffin embedded (FFPE) sample to this research.
8.Does not have any serious coexisting illness (e.g., poorly controlled diabetes mellitus or infectious disease, symptomatic interstitial pneumonia or pulmonary fibrosis, etc.).
9.Is expected to survive for at least 12 weeks from the enrollment date.
10.Willing to undergo investigative treatment according to the results of tissue genome profiling, blood genome profiling, reproductive cell lineage profiling and/or IHC.
Key exclusion criteria
1.Has a history of undergoing allogeneic hematopoietic stem cell transplantation or organ transplantation.
2.Is pregnant.
3.Has a history of another malignant tumor within the three years prior to enrollment.
4.Is judged to be ineligible for enrollment in this research by the study doctor.
Target sample size
2750
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
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, 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）、愛知県がんセンター（愛知県）、大阪大学医学部附属病院（大阪府）、金沢大学附属病院（石川県）、がん研究会有明病院（東京都）、杏林大学医学部付属病院（東京都）、国立病院機構九州がんセンター（福岡県）、慶應義塾大学病院（東京都）、近畿大学病院（大阪府）、埼玉県立がんセンター（埼玉県）、国立病院機構四国がんセンター（愛媛県）、静岡県立静岡がんセンター（静岡県）、聖マリアンナ医科大学病院（神奈川県）、千葉県がんセンター（千葉県）、北海道大学病院（北海道）、筑波大学附属病院（茨城県）、関西労災病院（大阪府）、九州大学病院（福岡県）、神奈川県立病院機構神奈川県立がんセンター（神奈川県）、大阪医療センター（大阪府）、香川大学医学部附属病院（香川県）、埼玉医科大学国際医療センター（埼玉県）、神戸市立医療センター中央市民病院（兵庫県）、岐阜大学医学部附属病院（岐阜県）、大阪医科薬科大学病院（大阪府）、島根県立中央病院（島根県）、関西医科大学附属病院（大阪府）、京都桂病院（京都府）、大阪国際がんセンター（大阪府）、大阪急性期・総合医療センター（大阪府）、三重大学医学部附属病院（三重県）、済生会福岡総合病院（福岡県）、徳島大学病院（徳島県）、広島大学病院（広島県）、市立豊中病院（大阪府）、東京慈会恵医科大学附属病院（東京都）、独立行政法人地域医療機能推進機構九州病院（福岡県）、鳥取大学医学部附属病院（鳥取県）、中部国際医療センター（岐阜県）、藤田医科大学病院（愛知県）、宝塚市立病院（兵庫県）、横浜市立大学附属市民総合医療センター（神奈川県）、松江市立病院（島根県）、高知大学医学部附属病院（高知県）、東北大学病院（宮城県）、虎の門病院（東京都）、亀田総合病院（千葉県）、倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 12 | 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
2768
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is observational research to evaluate the profiles of genetic abnormalities, RNA expression, and biomarkers in tumor tissue and ctNA and the profiles of germline genetic abnormalities in blood evaluated with blood genome profiling, and the results of protein expression in tumor tissue evaluated with tissue genome profiling and IHC, and the like, in terms of their relationship with clinical pathological factors, clinical course, etc.
Management information
Registered date
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050019
