UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055519 |
|---|---|
| Receipt number | R000063327 |
| Scientific Title | Comprehensive analysis of salivary metabolites in oral mucosal diseases |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2024/09/17 14:40:08 |
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Basic information
Public title
Research to determine diseases of the oral mucosa from salivary components.
Acronym
Saliva Composition Confirmation Test
Scientific Title
Comprehensive analysis of salivary metabolites in oral mucosal diseases
Scientific Title:Acronym
Comprehensive Analysis Study of Salivary Metabolites in Patients with Oral Mucosa Disease
Region
| Japan |
Condition
Condition
Leukoplakia, erythroplakia, oral lichen planus, oral candidiasis, xerostomia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify salivary metabolites associated with each oral mucosal disease using salivary metabolome analysis, and to apply this information to screening tests and new treatment methods for early detection of diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Components of saliva (salivary metabolites) collected in the morning on a given day of the week
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with leukoplakia, oral lichen planus, oral candidiasis, and xerostomia with confirmed diagnosis by pathology
Key exclusion criteria
Smokers, immunocompromised patients, severe diabetics
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | takuya |
| Middle name | |
| Last name | adachi |
Organization
Kanagawa Dental University
Division name
Department of Fixed Prosthodontics
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
0468228884
adachi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | takuya |
| Middle name | |
| Last name | adachi |
Organization
kanagawa dental university
Division name
Department of Fixed Prosthodontics
Zip code
2380006
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
09046521132
Homepage URL
unchou0502@gmail.com
Sponsor or person
Institute
kanagawa dental university
Institute
Department
Personal name
Funding Source
Organization
kanagawa dental 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
Kanagawa Dental university Research Ethics Review Committee
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
Tel
0468228884
kenkyo@kdu.ac.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
| 2024 | Year | 09 | Month | 29 | 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
| 2024 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The resting saliva and stimulated saliva of the disease group (leukoplakia, erythroplakia, oral lichen planus, oral candidiasis, xerostomia) and the control group (healthy subjects) will be collected on Monday and Tuesday mornings and flash frozen. Patients with immune disorders and smokers will be excluded. The subjects in both the disease and control groups must be 40 years of age or older. Resting saliva will be collected from the spontaneous flow of saliva for 15 minutes. Saliva is collected during stimulation for 10 minutes using gum. Saliva volume will be measured in both cases. The metabolites in saliva will then be analyzed by capillary electrophoresis (CE-MS).
Management information
Registered date
| 2024 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063327
