UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063626 |
|---|---|
| Receipt number | R000072795 |
| Scientific Title | Development and performance evaluation of a novel measurement method for urinary substances |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 18:09:12 |
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Basic information
Public title
Development and performance evaluation of a novel measurement method for urinary substances
Acronym
Development and performance evaluation of a novel measurement method for urinary substances
Scientific Title
Development and performance evaluation of a novel measurement method for urinary substances
Scientific Title:Acronym
Development and performance evaluation of a novel measurement method for urinary substances
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the analytical performance of a newly developed method for measuring multiple urinary substances (indoxyl sulfate, cortisol, 6-sulfatoxymelatonin, 8-hydroxy-2'-deoxyguanosine [8-OHdG], and pentosidine) by comparing it with existing methods using first-morning urine samples from healthy adults, and to determine the concentrations and concentration distributions of these substances by age group.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the analytical performance of a new measurement method (correlation and agreement with existing methods) and acquisition of age-specific data for establishing reference ranges in healthy adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between values measured by the existing and new methods for each urinary substance (Pearson's correlation coefficient, Spearman's rank correlation coefficient, and the regression equation and coefficient of determination from simple linear regression analysis)
Key secondary outcomes
1) Agreement between the methods (Bland-Altman analysis) and systematic differences between the methods (paired t-test or Wilcoxon signed-rank test)
2) Concentrations and concentration distributions of each urinary substance by age group and sex
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who have received a full explanation of the purpose and content of this study, have the capacity to consent, and, after fully understanding the study, have volunteered of their own free will and provided consent to participate via the web
2) Individuals aged 20 years or older at the time of consent
3) Individuals residing in Japan who are able to submit a urine sample to the research support organization at the designated date and time
Key exclusion criteria
1) Individuals who are receiving continuous medication for the treatment of a disease (individuals in their 70s with hypertension or hyperlipidemia will not be excluded; those taking medication for these conditions will be asked to report the name of the drug)
2) Individuals who regularly take sleeping medication
3) Individuals who are menstruating
4) Individuals who are pregnant
5) Individuals who are breastfeeding
6) Individuals who routinely engage in strenuous exercise (i.e., exercise for purposes beyond health promotion, such as participation in competitions)
7) Individuals whose daily pure alcohol intake is 40 g or more for men (approximately 2 go [360 mL] of sake, two 500-mL cans of beer, or 3 glasses of wine) or 20 g or more for women (approximately 1 go [180 mL] of sake, one 500-mL can of beer, or 2 glasses of wine)
8) Individuals who smoke habitually
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hideharu |
| Middle name | |
| Last name | Kurioka |
Organization
KYOCERA Corporation
Division name
Project 2, Social Deployment Department, Social Deployment Center, Corporate R&D Group
Zip code
612-8501
Address
6 Takeda Tobadono-cho, Fushimi-ku, Kyoto, Japan
TEL
075-604-3686
hideharu.kurioka.cy@kyocera.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Osawa |
Organization
3H Medi Solution Inc.
Division name
Project Management Team, Insight Clinical Research Group
Zip code
171-0022
Address
JRE Minami-Ikebukuro Bldg. 2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
osawa-takako@3h-ms.co.jp
Sponsor or person
Institute
KYOCERA Corporation
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Corporation
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
Ethics Review Board, Non Profit Organization Tokyo Allergy and Respiratory Disease Research Institute
Address
3F, Riverside Tower Kuramae, 1-8-6 Kuramae, Taito-ku, Tokyo
Tel
080-7360-0910
takahiro.chisaki@inclusion-p.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
| 2026 | Year | 11 | Month | 13 | 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
NO
IPD sharing Plan description
There is no plan to share individual participant data. Any secondary use or provision to other institutions of the information obtained in this study will be conducted as a new study after approval by an ethics committee.
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-invasive, non-interventional observational study.
Management information
Registered date
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072795
