UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056147 |
|---|---|
| Receipt number | R000064147 |
| Scientific Title | Establishment of rapid diagnostic method using mobile qPCR device (PCR1100) for viral infections |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2025/05/19 11:29:00 |
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Basic information
Public title
Establishment of rapid diagnostic method using mobile qPCR device (PCR1100) for viral infections
Acronym
Establishment of rapid diagnostic methods for viral infections
Scientific Title
Establishment of rapid diagnostic method using mobile qPCR device (PCR1100) for viral infections
Scientific Title:Acronym
Establishment of rapid diagnostic methods for viral infections
Region
| Japan |
Condition
Condition
herpes simplex, herpes zoster, herpesviruses 4 or 5 (HHV-4 or 5) related disease, hand-foot-and-mouth disease, herpangina, and respiratory syncytial virus (RS virus) infections.
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, diagnosis and treatment of viral infections are based on experience. However, since the accompanying symptoms and subsequent symptoms vary depending on the causative virus, it is important to accurately identify the causative virus at the time of the initial examination to ensure appropriate treatment. Therefore, our aim is to establish a rapid diagnostic method for viral infections using a mobile qPCR device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of Ct value immediately after test
Focuses only on diagnosis and does not require follow-up over time
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients who visited Tsurumi University Hospital, Saiseikai Yokohama Eastern Hospital, or Showa University Hospital and were suspected of having a viral disease, they received an explanation of this study and consented to this study of their own free will. The persons shall be men and women with no conflict of interest.
Key exclusion criteria
Informed consent or persons unable to obtain informed consent.
In addition, the event will be canceled if any of the following apply.
If a subject requests to decline research participation or withdraws consent.
If the research itself is discontinued.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Toda |
Organization
Tsurumi University
Division name
Department of Oral Medicine and Stomatology, School of Dental Medicine
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama City, 230-8501 Japan
TEL
045-580-8333
tokuyama-r@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Toda |
Organization
Tsurumi University
Division name
Department of Oral Medicine and Stomatology, School of Dental Medicine
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama City, 230-8501 Japan
TEL
045-580-8333
Homepage URL
tokuyama-r@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Oral Medicine and Stomatology, School of Dental Medicine, 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, School of Dental Medicine, Tsurumi University
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama City, 230-8501 Japan
Tel
045-580-8333
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
済生会横浜市東部病院(神奈川県）、昭和大学歯科病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | 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
4
Results
Currently, four patients suspected of having herpes simplex are participating, and rapid diagnosis was possible in all cases.
Results date posted
| 2025 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four patients suspected of having herpes simplex
Participant flow
Patients at Tsurumi University Dental Hospital and Saiseikai Yokohama City Eastern Hospital
Adverse events
nothing
Outcome measures
diagnosis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 12 | 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
None
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064147
