UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043788
Receipt No. R000049983
Scientific Title A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Date of disclosure of the study information 2021/03/30
Last modified on 2021/03/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Acronym A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Scientific Title A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Scientific Title:Acronym A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We explore the prevalence of antibodies against SARS-CoV-2 in oral surgery medical staff at multiple centers.
Basic objectives2 Others
Basic objectives -Others We establish evidence-based infection precaution protocols for COVID-19 by level.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the SARS-CoV-2 antibody prevalence in oral surgery medical staff
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Blood sampling (5 ml) will be performed once during the study period.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Persons who are employees in the field of oral surgery (dentists, dental hygienists, nurses, dental technicians) and who have obtained the consent of the document by their own free will after fully understanding when participating in this study.
Key exclusion criteria Persons who are judged to be ineligible for this study by the principal investigator.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Koga
Organization Tokyo Women's Medical University, School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email koga.yoko@twmu.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Koga
Organization Tokyo Women's Medical University, School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email koga.yoko@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, School of Medicine
Institute
Department

Funding Source
Organization sysmex Corporation
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 Tokyo Women's Medical University, School of Medicine
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel 03-3353-8111
Email koga.yoko@twmu.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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 30 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
2020 Year 12 Month 03 Day
Date of IRB
2020 Year 12 Month 03 Day
Anticipated trial start date
2021 Year 02 Month 10 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 30 Day
Last modified on
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049983

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.