UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050254 |
|---|---|
| Receipt number | R000057232 |
| Scientific Title | Comparison of detection sensibility of various specimen collection methods for respiratory infectious pathogens, and Gene sequence analysis of viral pathogens. |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/07/15 18:39:28 |
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Basic information
Public title
Comparison of detection sensibility of various specimen collection methods for respiratory infectious pathogens, and Gene sequence analysis of viral pathogens.
Acronym
Comparison of detection sensibility of various specimen collection methods for respiratory infectious pathogens, and Gene sequence analysis of viral pathogens.
Scientific Title
Comparison of detection sensibility of various specimen collection methods for respiratory infectious pathogens, and Gene sequence analysis of viral pathogens.
Scientific Title:Acronym
Comparison of detection sensibility of various specimen collection methods for respiratory infectious pathogens, and Gene sequence analysis of viral pathogens.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the easy self-specimen collection method which is suitable for Japanese people, perform Multiplex PCR on more than ten pathogens causing respiratory infections using specimens of nasopharyngeal swab, nasal swab, nasal discharge, phlegm and saliva that were collected respectively from Japanese women and men aged 50 years or older, and if pathogens are detected, the detection sensibility of each collection method will be compared.
If SARS-CoV-2, RSV and influenza viruses are detected, gene sequence analysis will be performed.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection sensibility in various specimen collection methods and gene sequence analysis.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects who gave written informed consent to participate in the trial.
2)Japanese women and men aged 50 years or older.
3)Subjects who have at least any one of the symptoms of common cold that occurred within 72 hours before the subject visit to the study site at the time of informed consent.
The symptoms of common cold are:
Nasal discharge, nasal congestion, pharyngitis, cough, wheezing, phlegm, shortness of breath, or body temperature of 37.5 C or higher.
Key exclusion criteria
Subjects who were considered by the investigator or subinvestigator to be ineligible for the participant in the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Furuie |
Organization
Medical Corporation Heishinkai OPHAC Hospital
Division name
none
Zip code
532-0003
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi,Osaka
TEL
06-6395-9000
hidetoshi.furuie@heishinkai.com
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Furuie |
Organization
Medical Corporation Heishinkai OPHAC Hospital
Division name
none
Zip code
532-0003
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi,Osaka
TEL
06-6395-9000
Homepage URL
hidetoshi.furuie@heishinkai.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Heishinkai OPHAC Hospital ERC
Address
4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN
Tel
06-6395-9000
ophach_irb@heishinkai.com
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
| 2023 | Year | 02 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057232
