UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052976 |
|---|---|
| Receipt number | R000060438 |
| Scientific Title | Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2024/12/17 15:50:07 |
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Basic information
Public title
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Acronym
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Scientific Title
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Scientific Title:Acronym
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the detection sensibility of four methods for collecting respiratory infectious pathogens from Japanese patients with respiratory infectious diseases. Four types of specimens (nasopharyngeal swabs, nasal swabs, nasal discharge, and saliva) will be collected from study subjects immediately after the onset of common cold-like symptoms and be subjected to multiplex PCR testing for more than 10 kinds of pathogens that cause respiratory infections. For specimens in which the pathogens are detected, the detection sensibility will be compared. In future vaccine development, the results of this study will help in selecting a highly sensitive detection method suitable for Japanese patients with respiratory infectious diseases in disease prevention studies.
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
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
<Cohort A>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who are able to call the study site immediately when they experience at least two of common cold-like symptoms, to collect the specimen by themselves within 6 hours from the time they experience the second symptoms, and to visit the study site on the designated date (within 72 hours from the time they experience the second symptoms).
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.
4.Subjects who are able to visit the study site within the designated period (3, 6, 9 and 12 months after the consent, and the end visit). When the number of subjects reaches the target, the study will be terminated early. In such a case, the end visit will be performed within 30 days after the termination date, and the three-monthly visits mentioned above will no longer be required.
<Cohort B>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who have at least two of common cold-like symptoms and are able to visit the study site within 72 hours of the onset of the second symptoms.
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.
Key exclusion criteria
Subjects who are assessed as ineligible for the study by the principal investigator or sub-investigator.
Target sample size
1000
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
532-003
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
InCROM Inc.
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6395-9000
sumiko.kawamoto@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 | 12 | Month | 06 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060438
