UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040481 |
|---|---|
| Receipt number | R000046203 |
| Scientific Title | Examination of a new inspection method for samples submitted by the inspection department (immunochromatographic sample) using NanoSuit method and tabletop SEM |
| Date of disclosure of the study information | 2020/05/22 |
| Last modified on | 2020/05/21 23:29:22 |
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Basic information
Public title
Examination of a new inspection method for immunochromatographic samples using NanoSuit method and tabletop SEM
Acronym
Examination of a new inspection method for immunochromatographic specimens by NanoSuit method
Scientific Title
Examination of a new inspection method for samples submitted by the inspection department (immunochromatographic sample) using NanoSuit method and tabletop SEM
Scientific Title:Acronym
Examination of a new inspection method for samples submitted by the inspection department (immunochromatographic sample) by NanoSuit method
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to detect with high sensitivity the conventional visual immunochromatographic determination by using a tabletop SEM. By comparing this test method with the conventional judgment method and quantitative immunological test method, it will lead to the selection of a better test method and the construction of an operation method.
Basic objectives2
Others
Basic objectives -Others
Confirmation of high sensitivity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the ratio of high sensitivity by comparing with visual immunochromatography and desktop SEM.
Key secondary outcomes
rRT-PCR data
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 are suspicious of influenza infection
Key exclusion criteria
No exclusion criteria
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideya |
| Middle name | |
| Last name | Kawasaki |
Organization
Hamamatsu University School of Medicine
Division name
Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center
Zip code
431-3125
Address
1-20-1 Handayama Higashi-ku Hamamatsu-shi Shizuoka-ken Japan
TEL
81-53-435-2504
gloria@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideya |
| Middle name | |
| Last name | Kawasaki |
Organization
Hamamatsu University School of Medicine
Division name
Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center
Zip code
431-3125
Address
1-20-1 Handayama Higashi-ku Hamamatsu-shi Shizuoka-ken Japan
TEL
81-53-435-2504
Homepage URL
gloria@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Hamamatsu University School of Medicine, ethics committee
Address
1-20-1 Handayama Higashi-ku Hamamatsu-shi Shizuoka-ken Japan
Tel
81-53-435-2680
rinri@hama-med.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
| 2020 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046203
