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 2024/02/03 19:54:45

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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

Email

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


Email

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

Email

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


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

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

2024 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name