UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061808 |
|---|---|
| Receipt number | R000070730 |
| Scientific Title | Study on biomarkers in saliva |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/05 14:42:54 |
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Basic information
Public title
Study on biomarkers in saliva
Acronym
Salivary biomarker research
Scientific Title
Study on biomarkers in saliva
Scientific Title:Acronym
Salivary biomarker research
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers in saliva that enable visualization of health status.
Basic objectives2
Others
Basic objectives -Others
Exploration of health indicators
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Components in saliva
Key secondary outcomes
Saliva secretion volume
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals within a specific age range (20 to 89 years old) who do not fall under the exclusion criteria.
Key exclusion criteria
1. Individuals with serious chronic diseases.
2. History of anemia, kidney disease, cerebrovascular disorder, cancer, chronic inflammation, or mental illness.
3. History of bariatric surgery or liposuction.
4. Major surgery or hospitalization within 6 months before the start of the study.
5. Pregnant or lactating women.
6. History of substance abuse.
7. Diagnosis of serious mental illness or dementia.
8. Current serious infectious diseases (HIV, hepatitis virus infection, etc.).
9. Habit of chronic alcohol consumption (alcoholism).
10. Individuals judged inappropriate as subjects based on the background questionnaire.
11. Individuals requiring nursing care certification.
12. Individuals with a daily smoking habit.
13. Diagnosis of abnormal oral environment (periodontal disease, etc.)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
umin@macromill.com
Public contact
Name of contact person
| 1st name | Anna |
| Middle name | |
| Last name | Kadodani |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
umin@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2026 | Year | 06 | Month | 08 | 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
| 2026 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort Study
Management information
Registered date
| 2026 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070730
