UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047687 |
|---|---|
| Receipt number | R000054371 |
| Scientific Title | Genetic analysis and clinical application of hearing loss |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2022/05/09 15:21:38 |
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Basic information
Public title
Genetic analysis and clinical application of hearing loss
Acronym
Genetic analysis of hearing loss
Scientific Title
Genetic analysis and clinical application of hearing loss
Scientific Title:Acronym
Genetic analysis of hearing loss
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aimed to clarify the genetic cause of Japanese hearing loss patients and also aimed to clinical application in clinical diagnostic use. From the results of this research we expected to clarify the clinical feature of each causative genes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic diagnosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hearing loss and their family member
Key exclusion criteria
Non
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Usami |
Organization
Shinshu University School of Medicine
Division name
Department of Hearing Implant Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-31-3802
usami@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin-ya |
| Middle name | |
| Last name | Nishio |
Organization
Shinshu University School of Medicine
Division name
Department of Hearing Implant Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
0263-31-3802
Homepage URL
nishio@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Shinshu university ethical community
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2572
mdrinri@shinshu-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 | 05 | Month | 09 | 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 | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Genetic Analysis
Pure tone audiometry or other auditory assessment.
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054371
