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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023299
Receipt No. 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 2018/01/23

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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
Last 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
Email kawashima.oto@tmd.ac.jp

Public contact
1st 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
Email fujikawa.oto@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026836

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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