UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060688 |
|---|---|
| Receipt number | R000069407 |
| Scientific Title | A Study on the Usefulness of Saliva-Based Cancer Risk Testing (SalivaChecker) |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/16 22:37:55 |
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Basic information
Public title
A Study on the Usefulness of Saliva-Based Cancer Risk Testing (SalivaChecker)
Acronym
Study on the Usefulness of Saliva-Based Cancer Risk Testing
Scientific Title
A Study on the Usefulness of Saliva-Based Cancer Risk Testing (SalivaChecker)
Scientific Title:Acronym
Study on the Usefulness of Saliva-Based Cancer Risk Testing
Region
| Japan |
Condition
Condition
participants undergoing comprehensive medical checkups
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will perform the SalivaChecker test on individuals undergoing comprehensive medical checkups and calculate the negative risk rate (specificity) among those who show no abnormalities in the checkup. Based on these findings, we will comprehensively evaluate the usefulness of saliva-based cancer risk assessment using the SalivaChecker test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculation of the Specificity of the SalivaChecker Test
Key secondary outcomes
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
participants undergoing comprehensive medical checkups
Key exclusion criteria
Individuals who did not provide consent.
Individuals with severe oral dryness that makes saliva collection difficult.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nagato |
| Middle name | |
| Last name | Natsume |
Organization
Aichi Gakuin University
Division name
Division of Research and Treatment for Oral and Maxillofacial Congenital Anomalies
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya
TEL
052-751-2561
natsume@dpc.aichi-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Umeda |
Organization
Aichi Gakuin University
Division name
Division of Research and Treatment for Oral and Maxillofacial Congenital Anomalies
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya
TEL
052-751-2561
Homepage URL
mumeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi-Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Japanese Society of Oral Care
Address
2-11 Suemoridori, Chikusa-ku, Nagoya
Tel
052-751-2561
office@oralcare-jp.org
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 | 02 | Month | 16 | 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
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069407
