UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049630 |
|---|---|
| Receipt number | R000056517 |
| Scientific Title | Exploration of biomarkers to visualize mitochondrial function |
| Date of disclosure of the study information | 2022/12/02 |
| Last modified on | 2023/12/27 13:10:59 |
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Basic information
Public title
Exploration of new health diagnostic markers
Acronym
Search for health diagnostic markers
Scientific Title
Exploration of biomarkers to visualize mitochondrial function
Scientific Title:Acronym
Search for mitochondrial function markers
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship between mitochondria function and biological factors
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between hearing loss and the other factors (Health check data was obtained from community resident annually from 2016 to 2017)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese men and women at age above 20 living in Iwaki area of Hirosaki City, Aomori Pref.
Key exclusion criteria
(1) Those with acute or exudative otitis media in their 20s or later
(2) Those with a history of sudden hearing loss
(3) Those with ear trauma
(4) Those with a history of ear surgery
(5) Those with cancer or a history of cancer
(6) Pregnant
(7) Those who are not fasting on the day of the exam
(8) Those with missing values in the following data
(Hearing, Lactic acid (metabolome data), Pyruvic acid (metabolome data),Mitochondrial haplo group, Age, Sex)
(9) Persons deemed inappropriate by the principal investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University, Graduate School of Medicine
Division name
Department of Stress Response Science
Zip code
036-8562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Itohk@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University, Graduate School of Medicine
Division name
Department of Stress Response Science
Zip code
036-8562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Homepage URL
Itohk@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Human Metabolome Technologies Inc.
2.KAGOME Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hirosaki University Graduate School of Medicine
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5044
rinri@hirosaki-u.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
| 2022 | Year | 12 | Month | 02 | 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
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data obtained at health check-up between 2016 and 2017 for the residents of Iwaki area of Hirosaki city, Aomori prefecture will be analyzed to clarify the relationship between mitochondria function and biological factor.
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
