UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046837 |
|---|---|
| Receipt number | R000053434 |
| Scientific Title | A Study on the Use of Oral Camera OC-11 and Olfaction Test for Prevention of Human-to-Human Infection in Large-Scale Events |
| Date of disclosure of the study information | 2022/02/05 |
| Last modified on | 2022/02/06 16:07:46 |
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Basic information
Public title
A Study on the Use of Oral Camera OC-11 and Olfaction Test for Prevention of Human-to-Human Infection in Large-Scale Events
Acronym
Using the OC-11 oral camera and olfaction testing
Scientific Title
A Study on the Use of Oral Camera OC-11 and Olfaction Test for Prevention of Human-to-Human Infection in Large-Scale Events
Scientific Title:Acronym
Using the OC-11 oral camera and olfaction testing
Region
| Japan |
Condition
Condition
upper respiratory tract infection
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate the possibility of effective prevention of human-to-human infection by early detection of changes caused by adhesion of pathogenic microorganisms to the upper respiratory tract
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of scalar imaging method in discriminating respiratory diseases
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
Outpatients of doctors who are members of the "Study Group for Prevention of Infectious Diseases by Using Oral Camera and Olfaction Test
Key exclusion criteria
Patients who are judged by the physician in charge to be inappropriate for enrollment as subjects in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tanigawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Public Health
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
tataniga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Wada |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Public Health
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
h-wada@juntendo.ac.jp
Sponsor or person
Institute
Department of Public Health,
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SCALA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation RESM Research Ethics Review Committee
Address
3-8-12 Shin-Yokohama, Kohoku-ku, Yokohama City, Kanagawa Prefecture
Tel
045-475-5155
N/A
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
| 2022 | Year | 02 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | 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
Research Design
Observational study
Method of recruitment of subjects
Patients who visited outpatient clinics of doctors who are members of the "Study Group for the Prevention of Infectious Diseases by Using Oral Camera and Olfaction Test
Management information
Registered date
| 2022 | Year | 02 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053434
