UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057419 |
|---|---|
| Receipt number | R000065607 |
| Scientific Title | Exploring Blood Biomarkers in patients with Hearing Loss |
| Date of disclosure of the study information | 2025/03/27 |
| Last modified on | 2025/03/27 09:34:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploring Blood Biomarkers in patients with Hearing Loss
Acronym
Biomarkers of hearing loss
Scientific Title
Exploring Blood Biomarkers in patients with Hearing Loss
Scientific Title:Acronym
Exploring Biomarkers of Hearing Loss
Region
| Japan |
Condition
Condition
hearing loss, vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform blood tests in patients with inner ear disorders to search for causes and biomarkers.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between hearing test (pure tone audiometry) and biomarkers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Blood test
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
Patients with inner ear disorders such as sudden hearing loss, Meniere's disease, presbycusis, vestibular neuritis, etc. who visit outpatient clinic in department of otorhinolaryngology in National institute of sensory organ Tokyo medical center
Key exclusion criteria
under 18 years of age, unconscious persons, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | SHO |
| Middle name | |
| Last name | KANZAKI |
Organization
National Institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center
Division name
Laboratory of Auditory Disorders,Auditory and Balance Research Division
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro Tokyo, Japan
TEL
0334110111
shokanza@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
National institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center
Division name
Laboratory of Auditory Disorders, Auditory and Balance Research Division
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro Tokyo
TEL
0353633827
Homepage URL
shokanza@yahoo.co.jp
Sponsor or person
Institute
National Institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center Clinical Research Center
Institute
Department
Personal name
Funding Source
Organization
The Uehara memorial foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguro Tokyo
Tel
0334110111
shokanza@yahoo.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
| 2025 | Year | 03 | Month | 27 | 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
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065607
