UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035754 |
|---|---|
| Receipt number | R000040682 |
| Scientific Title | Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2019/02/03 00:42:52 |
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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
| Infectious disease | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the influenza virus amount in various specimens at onset
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between influenza virus amount before onset and onset
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Influenza virus amount at onset
Key secondary outcomes
Influenza virus amount before onset
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who have fever up and/ or respiratory illness, and their families.
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Tabata |
Organization
School of Engineering, The University of Tokyo
Division name
Noji Laboratory
Zip code
Address
6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5841-7252
kazuhito@nojilab.t.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Tabata |
Organization
School of Engineering, The University of Tokyo
Division name
Noji laboratory
Zip code
Address
6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5841-7252
Homepage URL
kazuhito@nojilab.t.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 08 | 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 | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter study.
For patients with fever or respiratory symptoms and their families, samples are taken from nasal cavities and pharynx, and the amount of virus is measured. By investigating the amount of virus in various specimens and the progress of symptoms of the subjects, relationships between symptoms and the amount of virus are clarified.
Management information
Registered date
| 2019 | Year | 02 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
