UMIN-CTR Clinical Trial

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
Email	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
Email	wasano@a5.keio.jp

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042113