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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040481
Receipt No. 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

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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
Email 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
Email gloria@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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