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

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 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

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

Value
https://center6.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