UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045277 |
|---|---|
| Receipt number | R000051715 |
| Scientific Title | National survey for etiology of vocal fold scar |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/26 19:25:33 |
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Basic information
Public title
National survey for etiology of vocal fold scar
Acronym
Etiology of vocal fold scar
Scientific Title
National survey for etiology of vocal fold scar
Scientific Title:Acronym
Etiology of vocal fold scar
Region
| Japan |
Condition
Condition
vocal fold scar
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the etiology of vocal folds scar in Japan
Basic objectives2
Others
Basic objectives -Others
To develop treatment for vocal fold scar
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of new patients per year
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
Patients diagnosed Vocal fold scar
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Hirano |
Organization
Kyoto Prefectural University of Medicine
Division name
Otolaryngology
Zip code
602-8566
Address
Kajii-cho465, Kamigyo-ku
TEL
075-251-3010
hirano@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Hirano |
Organization
Kyoto Prefectural University of Medicine
Division name
Otolaryngology
Zip code
602-8566
Address
Kajii-cho465, Kamigyo-ku
TEL
0752513010
Homepage URL
hirano@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Kyoto Prefectural University of Medicine
Address
Kajiicho, Kamigyo-ku 465
Tel
0752513010
hirano@koto.kpu-m.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
| 2021 | 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
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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051715
