UMIN-CTR Clinical Trial

Basic information
Public title	Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus
Acronym	Development of rapid diagnosis kit for influenza virus
Scientific Title	Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus
Scientific Title:Acronym	Development of rapid diagnosis kit for influenza virus
Region	Japan

Condition
Condition	Influenza virus infection
Classification by specialty	Medicine in general Infectious disease Laboratory medicine Emergency medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of diagnostic accuracy by inspection method and site for influenza virus infection
Basic objectives2	Others
Basic objectives -Others	Survey of thresholds and conditions for influenza virus infection
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic accuracy for each specimen collection site and test method
Key secondary outcomes	Onset threshold of influenza virus infection

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	Device,equipment Maneuver
Interventions/Control_1	Sampling of oral mucosa, pharyngeal abrasion, nasopharyngeal swabs, nasal discharge, and saliva of patients and healthy people with dense contact
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 visited for complaints of influenza-like symptoms in an influenza virus infection endemic area, and its rich contact healthy people
Key exclusion criteria	nothing
Target sample size	400

Research contact person
Name of lead principal investigator	1st name kazuhito Middle name Last name tabata
Organization	University of Tokyo
Division name	Noji Laboratory, Department of Applied Chemistry
Zip code	113-8656
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5841-1872
Email	kazuhito@nojilab.t.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Kamagata
Organization	University of Tokyo
Division name	Noji Laboratory, Department of Applied Chemistry
Zip code	113-8656
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5841-1872
Homepage URL
Email	kamagatahrn1981@gmail.com

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	School of Engeneering, University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-8824
Email	anzen@anzen.t.u-tokyo.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	うちだ内科医院（東京都） 本郷耳鼻咽喉科クリニック（東京都） 道東の森総合病院（北海道〉 武蔵ヶ丘病院（熊本県） 葛が谷つばさクリニック(神奈川県）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 31 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 02 Month 15 Day
Date of IRB	2019 Year 02 Month 15 Day
Anticipated trial start date	2019 Year 12 Month 11 Day
Last follow-up date	2020 Year 05 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 12 Month 25 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044313