UMIN-CTR Clinical Trial

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
Email	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
Email	h-wada@juntendo.ac.jp

Sponsor
Institute	Department of Public Health, Juntendo University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053434