UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044435
Receipt No. 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 2021/06/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tokuyama-r@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University
Institute
Department

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 045-580-1001
Email tokuyama-r@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 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 Preinitiation
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
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.