UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012660 |
|---|---|
| Receipt number | R000014679 |
| Scientific Title | Analysis of herpes-specific cell-mediated immunity in patients with facial palsy |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2020/12/29 09:34:46 |
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Basic information
Public title
Analysis of herpes-specific cell-mediated immunity in patients with facial palsy
Acronym
herpes-specific cell-mediated immunity in facial palsy
Scientific Title
Analysis of herpes-specific cell-mediated immunity in patients with facial palsy
Scientific Title:Acronym
herpes-specific cell-mediated immunity in facial palsy
Region
| Japan |
Condition
Condition
Facial palsy (Bell's palsy and Ramsay Hunt syndrome)
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the characteristics of VZV-specific CMI in patients with facial palsy and to obtain suggestion of its role playing on occurrence of Hunt syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)To identify HSV or VZV DNA in tear and saliva using PCR procedure.
2)To measure HSV and VZV-specific immunoglobulin in patients' blood.
3)To measure VZV-specific cell-mediated immunity in patients with facial palsy using ELISPOT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
patients with facial palsy
6 months
blood collection 20ml, total 4 times
Interventions/Control_2
normal control (volunteer)
1 day
blood collection 20ml
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 with facial palsy
normal controls without facial palsy
Key exclusion criteria
patients or volunteers under 20 years old
patients or volunteers without their agreements
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kawata |
Organization
Osaka Medical College
Faculty of Medicine
Division name
Otolaryngology
Zip code
5698686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
oto034@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Haginomori |
Organization
Osaka Medical College
Division name
Otolaryngology
Zip code
5698686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
hagi@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
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
Kobe University Graduate School of Medicine/ School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Medical College
Address
2-7 Daigakumachi, Takatsuki, Osaka
Tel
072-683-1221
rinri@osaka-med.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
大阪医科大学（大阪府）
神戸大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014679
