UMIN-CTR Clinical Trial

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
Institute	Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050221