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

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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

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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name