UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053883 |
|---|---|
| Receipt number | R000061501 |
| Scientific Title | Exploratory Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/03/18 10:38:34 |
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Basic information
Public title
Exploratory Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Acronym
Exploratory Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Scientific Title
Exploratory Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Scientific Title:Acronym
Exploratory Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Region
| Japan |
Condition
Condition
Lung cancer, breast cancer, colon cancer, stomach cancer, esophagus cancer, ovary cancer, kidney cancer, urothelial cancer, prostate cancer, cervix cancer, brain tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Nephrology | Neurology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Laboratory medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. miRNA Analysis
We analyze the comprehensive miRNA profiles obtained from miRNA extracted from urine specimens of various cancer patients, brain tumor patients, and healthy adults, evaluating their correlation with clinical information obtained from routine examinations. For cancer types targeted by miSignal as of March 2024, our aim is to assess the improvement in diagnostic performance of predictive models, while for cancer types not targeted as of March 2024, we will construct new predictive models and evaluate the performance of these constructed models.
2. DNA Methylation Analysis
We comprehensively analyze the methylation patterns of cfDNA extracted from urine specimens of various cancer patients, brain tumor patients, and healthy adults, evaluating their correlation with clinical information obtained from routine examinations. In this analysis, we aim to construct new predictive models for all cancer types and evaluate the performance of these constructed predictive models.
Basic objectives2
Others
Basic objectives -Others
Exploratory Analysis of Other Urinary Biomarkers
We measured and analyzed other biomarkers (such as nucleic acids, proteins, metabolites, urinary constituents, etc.) extracted from urine specimens of various cancer patients, brain tumor patients, and healthy adults, and evaluated their correlation with clinical information obtained from routine examinations. In this analysis, we aim to explore the possibility of constructing new predictive models for all cancer types and brain tumors as listed in Table 2-1.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The specimens collected in this study are allocated to training and test datasets in approximately a 2:1 ratio. Using either miRNA expression levels or DNA methylation rates as features, machine learning is employed to construct predictive models optimized for the diagnostic performance of each cancer type and brain tumor. The diagnostic performance for each cancer type and brain tumor is evaluated using statistical measures such as AUC values, sensitivity, and specificity. In the analysis based on miRNA expression levels, for cancer types currently targeted by miSignal, a comprehensive evaluation with existing predictive models (e.g., through cross-validation) is conducted. As for other urinary biomarkers, since it is in an exploratory stage, specific evaluation criteria will be established using these specimens.
Key secondary outcomes
This study is a non-interventional clinical research, and there are no health risks to the study participants. Therefore, no information regarding safety is collected.
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
For Cancer Patients and Brain Tumor Patients
To participate in this study, individuals must meet all of the following criteria (1) to (4):
1. At the time of signing the consent form, the individual must be a Japanese national aged 18 years or older.
2. Using a consent document approved by the ethics review committee of each research institution, written consent must be obtained based on the free will of the individual or their proxy for participation in this study.
3. The individual must have been pathologically diagnosed with one of the following cancers or brain tumors with a clear primary site. The histological type and stage of cancer, as well as the classification and malignancy of brain tumors, are not relevant.
Lung cancer, breast cancer, colorectal cancer, stomach cancer, esophageal cancer, ovarian cancer, kidney cancer, urinary tract epithelial cancer, prostate cancer, cervical cancer
4. At the time of urine specimen collection, the individual must not have a history of treatment for cancer or brain tumors.
For Healthy Adults
To participate in this study, individuals must meet all of the following criteria (1) to (3):
1. At the time of signing the consent form, the individual must be a Japanese national aged 50 years or older.
2. Using a consent document approved by the Institutional Review Board (IRB) of each research institution, written consent must be obtained based on the free will of the individual.
3. Based on medical evaluation including medical history, physical examination, vital signs (blood pressure, pulse rate), and clinical laboratory tests, individuals must be determined by a physician to be in good health.
Key exclusion criteria
Individuals who meet any of the following criteria (1) to (5) at the time of specimen collection are not eligible to participate in this study:
(1) Those who are pregnant or may be pregnant.
(2) Women who are menstruating.
(3) Those with a history of malignant tumors or brain tumors.
(4) Those currently participating in intervention trials (including clinical trials) other than this study.
(5) Any other individuals deemed inappropriate by the physician of the research institution.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ichikawa |
Organization
Craif. Inc
Division name
Chief Technology Officer
Zip code
113-0034
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
clinicaltrial@craif.com
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Mikami |
Organization
Craif inc.
Division name
Clinical Development
Zip code
113-0034
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
self funded
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Craif Institutional Review Board
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
Tel
03-6801-8334
clinicaltrial@craif.com
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 | 18 | 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 | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | 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 | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061501
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