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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012660
Receipt No. 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 2020/06/29

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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
Email 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
Email hagi@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email 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 Open public recruiting
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

Other
Other related information

Management information
Registered date
2013 Year 12 Month 24 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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