UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023299 |
|---|---|
| Receipt number | R000026836 |
| Scientific Title | Mutation screening of deafness genes on patients with idiopathic hearing impairment. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/01/26 12:40:26 |
* 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
Mutation screening of deafness genes on patients with idiopathic hearing impairment.
Acronym
Mutation screening of deafness genes
Scientific Title
Mutation screening of deafness genes on patients with idiopathic hearing impairment.
Scientific Title:Acronym
Mutation screening of deafness genes
Region
| Japan |
Condition
Condition
Idiopathic hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose is further mutation screening of deafness gene on patients with idiopathic hearing loss.
Basic objectives2
Others
Basic objectives -Others
All genes listed in hereditary hearing loss homepage are subject to thistest.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of causative deafness gene
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
1. hereditary hearing loss
2. syndromic hearing loss
3. congenital hearing loss
4. idiopathic hearing loss
5. inner ear marformation
6. auditory neuropathy
Key exclusion criteria
1. no request for the test from patient or his family
2. gene candidate is unpredictable from clinical findings
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Kawashima |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
kawashima.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Fujikawa |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
Homepage URL
fujikawa.oto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2016 | Year | 09 | 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
We sampled DNA from a patient with IP-3 phenotype and parents, and analysed whole coding regions and multiple enhancer regions of POU3F4 by Sanger sequencing, resulting in no pathogenic variant detected.
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Bood sampling from patient, 10ml.
2. DNA extraction
3. Generate appropriate primer set for target gene.
4. Sequencing.
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026836
