UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053663 |
|---|---|
| Receipt number | R000059185 |
| Scientific Title | National Survey of Age-Related Vocal Fold Atrophy |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/20 19:37:43 |
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Basic information
Public title
National Survey of Age-Related Vocal Fold Atrophy
Acronym
National Survey of Age-Related Vocal Fold Atrophy
Scientific Title
National Survey of Age-Related Vocal Fold Atrophy
Scientific Title:Acronym
National Survey of Age-Related Vocal Fold Atrophy
Region
| Japan |
Condition
Condition
Age-Related Vocal Fold Atrophy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Age-related vocal cord atrophy is a condition in which the vocal cords atrophy with age, resulting in hoarseness and communication disorders. The aging population in Japan is rapidly progressing, and age-related vocal cord atrophy is a disease that will continue to increase in the future. However, the incidence of age-related vocal fold atrophy in Japan has not yet been established, nor have clear diagnostic criteria or severity classifications been established. Therefore, we aim to clarify the epidemiology of age-related vocal fold atrophy in Japan by conducting a nationwide survey of existing cases of age-related vocal fold atrophy in order to develop diagnostic criteria and severity classifications for age-related vocal fold atrophy cases. Understanding the epidemiology and treatment status of the disease is expected to serve as a foundation for building a database for the search of treatment guidelines.
Basic objectives2
Others
Basic objectives -Others
This survey was conducted at training facilities nationwide that are certified by the Japanese Society of Broncho-Esophagology as research collaborating institutions,
The survey will be conducted by (1) an overall questionnaire and (2) individual data collection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of hoarseness using the longest vocal duration and Voice Handicap Index - 10, age at first onset, duration of illness, if treatment was given, patient background, treatment modalities given to the individual, duration of treatment, and status of treatment efficacy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male and female patients over 20 years old
(2) Patients diagnosed with age-related vocal cord atrophy at each facility
Key exclusion criteria
(1) Patients who are determined to be ineligible by the physician's judgment
(2) Patients who have expressed their refusal to participate by opting out
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Watanabe |
Organization
International University of Health and Welfare
Division name
Tokyo Voice Center
Zip code
107-0052
Address
Sanno medical center, 8-5-35 Akasaka, Minato-ku, Tokyo 107-0052, Japan
TEL
0334025581
nabe@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Hasegawa |
Organization
International University of Health and Welfare
Division name
Tokyo Voice Center
Zip code
107-0052
Address
Sanno medical center, 8-5-35 Akasaka, Minato-ku, Tokyo 107-0052, Japan
TEL
0334025581
Homepage URL
t-hasegawa1@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
The Japan broncho-esophagological society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Junwa-kai Institutional Review Board
Address
Sanno Hospital, 8-10-16 Akasaka, Minato-ku, Tokyo 107-0052, Japan
Tel
03-3402-3151
t-mimura@iuhw.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
| 2024 | Year | 02 | Month | 22 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
