UMIN-CTR Clinical Trial

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
Email	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
Email	nishio@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054371

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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