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 |
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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
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
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
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
