UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056753 |
|---|---|
| Receipt number | R000064857 |
| Scientific Title | Identification of High-Risk Individuals Utilizing Steatotic Liver Disease |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/18 11:16:47 |
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Basic information
Public title
Identification of High-Risk Individuals Utilizing Steatotic Liver Disease
Acronym
Identification of High-Risk Individuals Utilizing Steatotic Liver Disease
Scientific Title
Identification of High-Risk Individuals Utilizing Steatotic Liver Disease
Scientific Title:Acronym
Identification of High-Risk Individuals Utilizing Steatotic Liver Disease
Region
| Japan |
Condition
Condition
Subjects who underwent a medical checkup and subjects with digestive system diseases including SLD
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between steatotic liver disease and other conditions, including digestive system diseases.
Basic objectives2
Others
Basic objectives -Others
To elucidate the relationship between steatotic liver disease and clinical background factors, including oral microbiota, as well as other conditions, including digestive system diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between steatotic liver disease and various diseases
Key secondary outcomes
The role of oral microbiota in steatotic liver disease and various other diseases
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
Subjects who underwent a medical checkup and subjects with digestive system diseases including SLD
Key exclusion criteria
None
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Sogabe |
Organization
Health Service, Counseling and Accessibility Center, Tokushima University
Division name
Health Service
Zip code
770-8502
Address
1-1 Minamijosanjima-cho, Tokushima city
TEL
088-656-7289
sogabe.masahiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Sogabe |
Organization
Health Service, Counseling and Accessibility Center, Tokushima University
Division name
Health Service
Zip code
770-8502
Address
1-1 Minamijosanjima-cho, Tokushima city
TEL
088-656-7289
Homepage URL
sogabe.masahiro@tokushima-u.ac.jp
Sponsor or person
Institute
Shikoku Central Hospital of the Mutual aid Association of Public School Teachers
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
not applicable
Address
not applicable
Tel
not applicable
not applicable
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
| 2025 | Year | 04 | Month | 01 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To elucidate the relationship between steatotic liver disease and clinical background factors, including oral microbiota, as well as other conditions, including digestive system diseases.
Management information
Registered date
| 2025 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064857
