UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043968
Receipt number R000050221
Scientific Title Super-rapid diagnosis of viral infections by single virus detection with solid-state nanopore
Date of disclosure of the study information 2021/04/20
Last modified on 2022/10/26 17:52:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Super-rapid diagnosis of viral infections by single virus detection with solid-state nanopore

Acronym

Super-rapid diagnosis of viral infections by single virus detection with solid-state nanopore

Scientific Title

Super-rapid diagnosis of viral infections by single virus detection with solid-state nanopore

Scientific Title:Acronym

Super-rapid diagnosis of viral infections by single virus detection with solid-state nanopore

Region

Japan


Condition

Condition

Viral infection

Classification by specialty

Medicine in general Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By detecting a single virus molecule in a short time using a nanopore detector and analyzing the data using artificial intelligence, we can diagnose viral infections in an extremely short time.

Basic objectives2

Others

Basic objectives -Others

To calculate the sensitivity and specificity of virus detection and to verify whether the test method is clinically applicable.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Detection, Specificity and Sensitivity of Viruses in Samples Obtained from Patients with Viral Infectious Diseases in Ophthalmology

Key secondary outcomes

Correlation with quantitative PCR, the teacher data, and quantitative


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Anterior chamber fluid collection and corneal abrasion and blood 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

10 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with suspected viral eye infections

Key exclusion criteria

none

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Noiryasu
Middle name
Last name Hashida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

565-0871

Address

2-2 E7, Yamada-oka, Suita, Osaka, Japan

TEL

+81668793456

Email

nhashida@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name NORIYASU
Middle name
Last name HASHIDA

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

565-0871

Address

2-2 E7, Yamada-oka, Suita, Osaka, Japan

TEL

+81668793456

Homepage URL


Email

nhashida@ophthal.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Osaka University Graduate School of Medicine

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

Osaka University Graduate School of Medicine

Address

2-2, Yamada-oka, Suita, Osaka, Japan

Tel

+81668793456

Email

nhashida@ophthal.med.osaka-u.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

2021 Year 04 Month 20 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

Open public recruiting

Date of protocol fixation

2014 Year 06 Month 10 Day

Date of IRB

2014 Year 06 Month 10 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2026 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

2021 Year 04 Month 19 Day

Last modified on

2022 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050221


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name