UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049694 |
|---|---|
| Receipt number | R000056602 |
| Scientific Title | Accuracy validation of AI-assisted diagnosis for influenza during the novel coronavirus disease pandemic. |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2025/03/31 12:00:26 |
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Basic information
Public title
Accuracy validation of AI-assisted diagnosis for influenza during the novel coronavirus disease (COVID-19) pandemic.
Acronym
nodoca 2022-1
Scientific Title
Accuracy validation of AI-assisted diagnosis for influenza during the novel coronavirus disease pandemic.
Scientific Title:Acronym
nodoca 2022-1
Region
| Japan |
Condition
Condition
COVID-19, Influenza
Classification by specialty
| Medicine in general | Infectious disease | Pediatrics |
| Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the sensitivity and specificity of nodoca.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of Influenza AI compared to RT-PCR analysis for influenza.
Key secondary outcomes
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with written consent to participate in the study provided by themselves or their representatives.
(2) Patients aged three years or older.
(3) Patients with influenza-like symptoms within 48 hours after onset.
(4) Patients whose nasopharyngeal swabs were collected for RT-PCR testing of influenza within six hours prior to imaging, or patients whose nasopharyngeal swabs are scheduled to be collected for RT-PCR testing of influenza within six hours after the imaging.
(5) Patients whose nasopharyngeal swabs were collected for RT-PCR testing of SARS-CoV-2 within six hours before imaging, or patients whose nasopharyngeal swabs are scheduled to be collected for RT-PCR testing of SARS-CoV-2 within six hours after the imaging.
Key exclusion criteria
(1) Patients with fluctuating teeth.
(2) Patients with moderate or severe dental diseases.
(3) Patients who underwent oropharyngeal procedure such as oropharyngeal swab collection within six hours.
(4) Patients who have been vomiting repeatedly.
(5) Patients judged to be inappropriate to participate in the study by the physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mikawa |
Organization
Yamanashi Prefectural Central Hospital
Division name
Department of General Internal Medicine and Infectious Diseases
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu City, Yamanashi, Japan.
TEL
055-253-7111
mikawa-bfhh@ych.pref.yamanashi.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Mikawa |
Organization
Yamanashi Prefectural Central Hospital
Division name
Department of General Internal Medicine and Infectious Diseases
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu City, Yamanashi, Japan.
TEL
055-253-7111
Homepage URL
mikawa-bfhh@ych.pref.yamanashi.jp
Sponsor or person
Institute
Yamanashi Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamanashi Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aillis, Inc., University of Yamanashi Hospital
Name of secondary funder(s)
Aillis, Inc.
IRB Contact (For public release)
Organization
Yamanashi Prefectural Central Hospital IRB
Address
1-1-1 Fujimi, Kofu City, Yamanashi, Japan.
Tel
055-253-7111
clinical-research@ych.pref.yamanashi.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
| 2022 | Year | 12 | Month | 05 | 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
108
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Resubmitting after rejection
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
To compare the results of nodoca with RT-PCR analysis.
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056602
