UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017807 |
|---|---|
| Receipt number | R000020633 |
| Scientific Title | Search for hearing loss genes using next generation sequencer |
| Date of disclosure of the study information | 2015/06/04 |
| Last modified on | 2022/12/09 16:36:58 |
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Basic information
Public title
Search for hearing loss genes using next generation sequencer
Acronym
Search for hearing loss genes using next generation sequencer
Scientific Title
Search for hearing loss genes using next generation sequencer
Scientific Title:Acronym
Search for hearing loss genes using next generation sequencer
Region
| Japan |
Condition
Condition
sensory hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Search for hearing loss genes and make a panel dor diagnosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Search for new hearing loss genes
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
blood collection
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
bilateral sensory healing loss in audiogram
Key exclusion criteria
impossible to collect parents blood
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamasoba |
Organization
University of Tokyo
Division name
Departmnet of Otolaryngology, Head and Neck Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku,Tokyo, 113-8655, JAPAN
TEL
0358008665
tyamasoba-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamasoba |
Organization
University of Tokyo
Division name
Otolaryngology, Head and Neck SurgeryJAPAN
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku,Tokyo, 113-8655, JAPAN
TEL
0358008665
Homepage URL
tyamasoba-tky@umin.ac.jp
Sponsor or person
Institute
Departmnet of Otolaryngology,
Head and Neck Surgery
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of cardiology of Osaka university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Departmnet of Otolaryngology, Head and Neck Surgery University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku,Tokyo, 113-8655, JAPAN
Tel
03-3815-5411
tyamasoba-tky@umin.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
東京大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 04 | 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
140
Results
25 patients have deafness gene variants.
Results date posted
| 2022 | Year | 12 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Target sequence Delay
Date of the first journal publication of results
Baseline Characteristics
hearing loss patient
Participant flow
Blood collction
Adverse events
none
Outcome measures
DNA variants
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
