UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049773 |
|---|---|
| Receipt number | R000056687 |
| Scientific Title | Liquid Biopsy Exploration of Genetic Factors Determining the Timing of Onset of Hearing Loss Due to GJB2 Mutations |
| Date of disclosure of the study information | 2022/12/14 |
| Last modified on | 2022/12/13 20:35:38 |
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Basic information
Public title
Liquid Biopsy Exploration of Genetic Factors Determining the Timing of Onset of Hearing Loss Due to GJB2 Mutations
Acronym
Liquid Biopsy Exploration of Genetic Factors Determining the Timing of Onset of Hearing Loss Due to GJB2 Mutations
Scientific Title
Liquid Biopsy Exploration of Genetic Factors Determining the Timing of Onset of Hearing Loss Due to GJB2 Mutations
Scientific Title:Acronym
Liquid Biopsy Exploration of Genetic Factors Determining the Timing of Onset of Hearing Loss Due to GJB2 Mutations
Region
| Japan |
Condition
Condition
Hearing Loss Due to GJB2 Mutations
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Explore the genetic factors that determine the timing of onset and severity of symptoms of hearing loss caused by GJB2 mutations
Basic objectives2
Others
Basic objectives -Others
Genome analysis of patients with GJB2 mutations will be performed to search for differences in methylation and modifier gene sequences
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Differential methylation in hearing loss-related genes
Key secondary outcomes
Sequence Differences in Hearing Loss-Related Genes
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
hearing loss patients having GJB2 gene mutations
Key exclusion criteria
Subjects and blood relatives suffering from serious developmental, infectious, or neurological diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Anzai |
Organization
Juntendo University
Division name
Department of Otorhinolaryngology, Graduate School of Medicine
Zip code
113-8431
Address
Bunkyou-ku, Hongo3-1-3, Tokyo
TEL
03-3813-3111
tanzai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Ikeda |
Organization
Juntendo University
Division name
Department of Otorhinolaryngology, Graduate School of Medicine
Zip code
113-8431
Address
Bunkyou-ku, Hongo3-1-3, Tokyo
TEL
03-3813-3111
Homepage URL
ike@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bureau of Research Ethics Committee Faculty of Medicine, Juntendo University
Address
Bunkyou-ku, Hongo3-1-3, Tokyo
Tel
03-5802-1584
N/A
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 | 12 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will isolate gDNA and cfDNA from blood samples of patients with hearing loss who have mutations in the GJB2 gene and perform genomic analysis to search for genetic factors that determine the severity of symptoms.
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056687
