UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057434 |
|---|---|
| Receipt number | R000065625 |
| Scientific Title | Multicenter Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2025/08/19 15:40:57 |
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Basic information
Public title
Multicenter Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Acronym
Multicenter Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Scientific Title
Multicenter Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Scientific Title:Acronym
Multicenter Study on Diagnostic Performance of Multi-Cancer using Machine Learning Models with Urinary Biomarkers
Region
| Japan |
Condition
Condition
Pancreatic cancer, lung cancer, breast cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, kidney cancer, urothelial cancer, prostate cancer, cervical cancer, uterine cancer, liver cancer, gallbladder and bile duct cancer, head and neck cancer, hematological malignancies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Nephrology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Urology | Oral surgery | Laboratory medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. miRNA Analysis
miRNA profiles obtained from urine samples of each cancer patient and healthy adults will be comprehensively analyzed to evaluate the relevance to clinical information obtained in usual medical practice.
2. DNA methylation Analysis
Methylation patterns of cfDNA extracted from urine samples of each cancer patient and healthy adults will be comprehensively analyzed to evaluate the relevance to clinical information obtained in usual medical practice.
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 and healthy adults, and evaluated their correlation with clinical information obtained from routine examinations.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) miRNA expression level or (2) DNA methylation rate will be measured and the performance of the prediction model constructed by machine learning using these as features will be evaluated. The diagnostic performance for each cancer type will be evaluated based on statistics such as AUC value, sensitivity and specificity. As other biomarkers in urine are still in the exploratory stage, specific evaluation will be conducted from the setting of specific evaluation contents.
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]
To participate in this study, you must meet all of the following criteria (1) through (4).
(1) Be 18 years of age or older as of the date of signing the consent form.
(2) The patient is able to obtain written consent for participation in this study based on the free will of the patient or a surrogate, using a consent document approved by the Ethical Review Committee of the respective research institution.
(3) The patient has been diagnosed with one of the following cancers, the primary site of which is known. The histological type and stage of the cancer are not questioned.
Pancreatic cancer, lung cancer, breast cancer, colorectal cancer, stomach cancer, esophageal cancer, ovarian cancer, kidney cancer, urothelial carcinoma, prostate cancer, cervical cancer, uterine cancer, liver cancer, gallbladder and bile duct cancer, head and neck cancer (any site), hematopoietic tumor (malignant lymphoma, leukemia, multiple myeloma)
(4) There is no history of treatment for cancer at the time the urine specimen is collected.
[For healthy adults]
To participate in this study, you must meet all of the following criteria (1) through (3).
(1) Japanese nationals who are between 40 and 90 years of age on the date of signing the consent form.
(2) The individual or surrogate is able to obtain written consent for participation in this study based on his/her own free will using a consent document approved by the ethics review committee of the respective research institution, etc.
(3) Persons who are judged by a physician to be in good health based on a medical evaluation including history, physical examination, vital signs (blood pressure, pulse rate), and clinical laboratory values.
Key exclusion criteria
Persons who meet any of the following criteria (1) through (6) at the time of specimen collection will not be included in this study.
(1) Women who are pregnant or may become pregnant.
(2) Women who are menstruating at the time of scheduled urine sample collection.
(3) Those with a history of malignancy within the past 5 years.
(4) Patients with multiple cancers whose primary tumor is located in more than one organ.
(5) Who are currently participating in an interventional study (including a clinical trial) other than this study.
(6) Any other person who is deemed inappropriate by the investigator.
Target sample size
2200
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
162-0814
Address
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, 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
162-0814
Address
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
Craif Inc.
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
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, 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
| 2025 | Year | 03 | Month | 28 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065625
