UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036967 |
|---|---|
| Receipt number | R000042113 |
| Scientific Title | Development of early diagnosis method of virus detection in facial palsy patients |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2019/06/05 09:03:07 |
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Basic information
Public title
Development of early diagnosis method of virus detection in facial palsy patients
Acronym
Development of early diagnosis method of virus detection in facial palsy patients
Scientific Title
Development of early diagnosis method of virus detection in facial palsy patients
Scientific Title:Acronym
Development of early diagnosis method of virus detection in facial palsy patients
Region
| Japan |
Condition
Condition
peripheral facial palsy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of early diagnosis method of virus detection in acute peripheral facial palsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of sensitivity and specificity of the virus detection from saliva collected at first visit and 2-4 weeks after first visit.
Key secondary outcomes
Development of the most sensitive and specific primer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
The detection of virus using saliva collected from facial palsy patients
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Facial palsy patients who are 20 years old or over after written informed consent was obtained.
Key exclusion criteria
N/A
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Wasano |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Hearing and Balance Research, National Institute of Sensory Organs
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
wasano@a5.keio.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Wasano |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Hearing and Balance Research, National Institute of Sensory Organs
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
wasano@a5.keio.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
国立病院機構東京医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 05 | 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
| 2019 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042113
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
