UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039810 |
|---|---|
| Receipt number | R000045400 |
| Scientific Title | Registry study for Spasmodic Dysphonia |
| Date of disclosure of the study information | 2020/03/13 |
| Last modified on | 2023/09/23 09:35:17 |
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Basic information
Public title
RSSD
Acronym
Registry study for Spasmodic Dysphonia
Scientific Title
Registry study for Spasmodic Dysphonia
Scientific Title:Acronym
RSSD
Region
| Japan |
Condition
Condition
Spasmodic Dysphnonia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understand the number of patients with spasmodic dysphonia, patient background information, and treatment information.
Basic objectives2
Others
Basic objectives -Others
Contribute to the development and establishment of new treatments in the future
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of patients
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 (including minors) who have been diagnosed as having "convulsive" or "suspect" spasmodic dysphonia based on "diagnostic criteria and severity classification"
Key exclusion criteria
1) Follow the exclusion criteria described in spasmodic dysphonia diagnostic criteria and severity classification.
2) In addition, patients judged to be inappropriate as subjects by the judgment of researchers etc.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuji |
| Middle name | |
| Last name | sanuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
4678601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku, Nagoya 467-8601,Japan
TEL
0528535256
otostl@gmail.com
Public contact
Name of contact person
| 1st name | Tetsuji |
| Middle name | |
| Last name | sanuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
4678601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku, Nagoya 467-8601,Japan
TEL
0528535256
Homepage URL
http://www.rssd.umin.jp/
otostl@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
0757534680
ethcom@kuhp.kyoto-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
| 2020 | Year | 03 | Month | 13 | 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
| 2019 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collaboration with Rare Disease Data Registry of Japan
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045400
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
