UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061395 |
|---|---|
| Receipt number | R000070244 |
| Scientific Title | Investigation of Urological Cancer Biomarkers by Analyzing Exosome-derived MicroRNA |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 21:47:56 |
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Basic information
Public title
Investigation of Urological Cancer Biomarkers by Analyzing Exosome-derived MicroRNA
Acronym
EMBUC study: Exosomal MicroRNA-based Biomarkers for Urinary tract Cancer
Scientific Title
Investigation of Urological Cancer Biomarkers by Analyzing Exosome-derived MicroRNA
Scientific Title:Acronym
EMBUC study: Exosomal MicroRNA-based Biomarkers for Urinary tract Cancer
Region
| Japan |
Condition
Condition
Renal, Urothelial, and Prostate cancers
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To achieve early diagnosis of the three major urological cancers (renal, urothelial, and prostate cancers) by analyzing exosomal microRNAs in body fluids such as blood, urine, and saliva.
Basic objectives2
Others
Basic objectives -Others
To assess whether these microRNAs are associated with prognosis and treatment response in the three major urological cancers and can be used as biomarkers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC (area under the ROC curve) for discriminating cancer vs non-cancer
Key secondary outcomes
sensitivity and specificity
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
| 10 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients at our institution who are currently undergoing or are expected to undergo treatment for renal, urothelial, or prostate cancer will be included. In addition, patients with benign conditions, such as urolithiasis and benign prostatic hyperplasia, who visit or are admitted for treatment will be enrolled as controls.
Key exclusion criteria
Patients without informed consent
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Kosaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3825
takemduro@gmail.com
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3825
Homepage URL
urotanaka@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
CRAIF Inc.
Name of secondary funder(s)
CRAIF Inc.
IRB Contact (For public release)
Organization
Keio University school of Medicine
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3825
urotanaka@keio.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
慶應大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine the association between exosomal microRNAs obtained from body fluids of patients with urological cancers who are receiving care at our institution and their survival outcomes and clinical parameters. To compare these profiles with those of healthy individuals, exosomal microRNA analysis will also be conducted using body fluid samples from patients with benign urological conditions (e.g., urolithiasis and benign prostatic hyperplasia) treated at our institution. This is a prospective study analyzing blood, urine, and saliva samples collected during routine clinical care, and the results will not be used to guide treatment decisions. Exosomal microRNA analysis will be outsourced to Craif Inc., our collaborating institution. In addition, anonymized clinical data, including medical records, laboratory test results, and imaging data, will be provided to the company and used for cancer diagnosis and prognostic modeling using machine learning. Furthermore, exosomal microRNA data from healthy individuals without urological diseases, held by Craif Inc., will be provided and used as control data in the analysis.
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070244
