UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053815 |
|---|---|
| Receipt number | R000061338 |
| Scientific Title | Clinical Development of Molecular Residual Disease (MRD) and Multi-Cancer Early Detection (MCED) using Liquid Biopsy Multiomics Based on Artificial Intelligence (AI) |
| Date of disclosure of the study information | 2024/03/09 |
| Last modified on | 2024/03/09 16:28:42 |
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Basic information
Public title
Research aimed at the development of early cancer detection methods by comprehensively examining changes in DNA, RNA, proteins, metabolites, and the microbiome.
Acronym
Research aimed at the development of early cancer detection methods by comprehensively examining changes in DNA, RNA, proteins, metabolites, and the microbiome.
Scientific Title
Clinical Development of Molecular Residual Disease (MRD) and Multi-Cancer Early Detection (MCED) using Liquid Biopsy Multiomics Based on Artificial Intelligence (AI)
Scientific Title:Acronym
Clinical Development of Molecular Residual Disease (MRD) and Multi-Cancer Early Detection (MCED) using Liquid Biopsy Multiomics Based on Artificial Intelligence (AI)
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to establish an "AI Classifier" for predicting the presence and type of cancer using liquid biopsy mult-omics. This will be achieved through integrated analysis utilizing molecular profile information obtained from the CONDUCTOR trial, which focuses on genetic profiling and clinical significance using clinical specimens from cancer patients, as well as from the Tohoku Medical Megabank (ToMMo) project, and the MONSTAR-SCREEN-3 project, scheduled to begin in the fiscal year 2024, which is dedicated to researching molecular profiling platforms for malignant tumors.
Basic objectives2
Others
Basic objectives -Others
to develop "MRD (Minimal Residual Disease) / MCED (Minimal Clinically Evident Disease) assays" using liquid biopsy mult-omics.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the clinical performance (sensitivity, specificity, etc.) of the developed MRD and MCED assays
Key secondary outcomes
To evaluate the clinical performance (sensitivity, specificity, etc.) of the developed MRD and MCED assays by cancer type, clinical stage, 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The participant must have participated in the CONDUCTOR study as of March 2025, have not withdrawn consent, and have not refused secondary use of the information or sample.
2) Participants in the CONDUCTOR study must be at least 18 years old.
3) You have participated in the "Tohoku Medical Megabank Project Three Generations Cohort Study" or "Tohoku Medical Megabank Project Community Cohort Study" (hereinafter referred to as "ToMMo") between May 2013 and March 2025, have not withdrawn your consent, and have not refused secondary use of information and samples. In addition, if blood samples are to be collected for a clinical performance study, written consent for participation in this study has been obtained from the individual based on his/her voluntary will.
4) There is no history of malignancy in the ToMMo main body study participants in 3).
5) The ToMMo main study participant in 3) must be between 20 and 75 years of age.
Key exclusion criteria
The person in charge of this research is judged as not having sufficient ability to make decisions regarding the implementation of this research.
Target sample size
1400
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, Chiba
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Shibuki |
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, Chiba
TEL
04-7133-1111
Homepage URL
tshibuki@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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-111
irst@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 | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 19 | 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
none
Management information
Registered date
| 2024 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061338
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| Research case data | |
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