UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038997 |
|---|---|
| Receipt number | R000044313 |
| Scientific Title | Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2019/12/25 17:46:35 |
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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
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
kamagatahrn1981@gmail.com
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044313
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
