UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012178 |
|---|---|
| Receipt number | R000014185 |
| Scientific Title | Clinical research on application of the influenza virus detection with the nucleic acid detecting method |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2024/06/21 15:24:55 |
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Basic information
Public title
Clinical research on application of the influenza virus detection with the nucleic acid detecting method
Acronym
Clinical research on application of the influenza virus detection with the nucleic acid detecting method
Scientific Title
Clinical research on application of the influenza virus detection with the nucleic acid detecting method
Scientific Title:Acronym
Clinical research on application of the influenza virus detection with the nucleic acid detecting method
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research of a nucleic acid detection diagnostic method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Influenza infection early detection
Epidemiological data
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Swab collection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient with flulike symptom
2.The person by whom the informed consent document was got
Key exclusion criteria
1. Patient Who Does Not Meet Above-mentioned Selection Criterion
2. Subject Who Judged that Doctor was Unsuitable
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hori |
Organization
Juntendo University Graduate school of medicine
Division name
Department of infection control
Zip code
113-8431
Address
2-1-1 hongo bunkyo tokyo 113-8421 Japan
TEL
03-3813-3111
shori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yano |
Organization
K.K.DNAFORM
Division name
Regulatory Affairs Dept.
Zip code
230-0045
Address
Life Science Research Center 302, 1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa 230-0045 Japan
TEL
045-633-4240
Homepage URL
kazuhiro.yano@dnaform.jp
Sponsor or person
Institute
K.K.DNAFORM
Institute
Department
Personal name
Funding Source
Organization
K.K.DNAFORM
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
juntendo hospital IRB
Address
2-1-1 hongo bunkyo tokyo 113-8421 Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014185
