UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044435 |
|---|---|
| Receipt number | R000050475 |
| Scientific Title | Establishment of SARS-CoV-2 rapid screening test for COVID-19 diagnosis using small amount of saliva as a sample and examination of usefulness of mobile type qPCR device (PCR1100) |
| Date of disclosure of the study information | 2021/06/07 |
| Last modified on | 2023/06/06 09:53:03 |
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Basic information
Public title
Establishment of COVID-19 diagnostic method by new PCR device using a small amount of saliva as a sample
Acronym
Establishment of COVID-19 diagnostic method using a small amount of saliva as a sample
Scientific Title
Establishment of SARS-CoV-2 rapid screening test for COVID-19 diagnosis using small amount of saliva as a sample and examination of usefulness of mobile type qPCR device (PCR1100)
Scientific Title:Acronym
Establishment of COVID-19 diagnostic method using a new mobile qPCR device using a small amount of saliva as a sample
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Oral surgery | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
COVID-19 by SARS-CoV-2, which was confirmed to occur in 2019, is rampant all over the world, and its containment has become a serious and urgent global issue. For the definitive diagnosis of SARS-CoV-2 infection, detection of viral RNA by qPCR is currently the most reliable and widely used worldwide. However, since the current qPCR test is premised on being performed by a skilled specialist or clinical laboratory technician, securing human resources who can perform the qPCR test and qPCR test equipment is an important practical issue. Therefore, in order to realize effective containment of COVID-19 in the future, it is strongly required to expand the qPCR test for SARS-CoV-2 and to establish a new qPCR test method that can obtain diagnostic results in a short timing.
On the other hand, recently, a small and portable mobile real-time qPCR device has been developed for research purposes. This device (PCR1100) is compact and lightweight with a body size of H200 x W100 x D50 mm and a weight of about 560 g, and has excellent performance with an actual measurement time of about 10 minutes at the shortest by real-time PCR. It is expected that the time required for qPCR testing can be significantly reduced even in the field.
Therefore, in this study, we will investigate whether SARS-CoV-2 RNA can be detected using this device using mouthwash (or saliva) as a sample in actual COVID-19-infected persons. In addition, the consistency between the two tests will be examined by comparing with the results of the current qPCR test. Furthermore, we will consider whether or not the qPCR test can be performed over time according to the test implementation status during the hospitalization period at the cooperating medical facility, which will be a useful index for grasping the recovery status of the medical condition and deciding to discharge the hospital.
Basic objectives2
Others
Basic objectives -Others
Effectiveness of diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Similar results can be obtained with the new mobile-type qPCR device used in this study using samples from COVID-19-positive patients.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients who are hospitalized or scheduled to be hospitalized under a definitive diagnosis of COVID-19, adult men and women who have no interest and have consented to this study at their own free will after receiving the explanation of this study.
In addition, all of the following criteria shall be met.
(1) A definitive diagnosis has been obtained by the current qPCR test.
(2) Patients with symptoms that allow them to wash their mouth.
Key exclusion criteria
Those who fall under any of the following are excluded.
(1) Persons who cannot obtain informed consent by themselves.
(2) Persons who cannot wash their mouth by themselves.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Satomura |
Organization
Tsurumi University
Division name
Department of Oral Medicine and Stomatology
Zip code
2308501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa 230-8501, JAPAN
TEL
045-580-1001
satomura-r@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Tokuyama-Toda |
Organization
Tsurumi University
Division name
Department of Oral Medicine and Stomatology
Zip code
2308501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa 230-8501, JAPAN
TEL
045-580-1001
Homepage URL
tokuyama-r@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Yokohamashi Tobu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa 230-8501, JAPAN
Tel
045-580-8317
kyoken@tsurumi-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
鶴見大学（神奈川県）、済生会横浜市東部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/11/11/2024
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 06 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 06 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 06 | Day |
Other
Other related information
Only saliva collection, no intervention to the subject.
Only the results of qPCR should be observed.
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050475
