UMIN-CTR Clinical Trial

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