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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032099
Receipt No. R000036624
Scientific Title A study for of the infection status of Epstein-Barr virus in healthy young adults
Date of disclosure of the study information 2018/06/01
Last modified on 2021/10/11

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Basic information
Public title A study for of the infection status of Epstein-Barr virus in healthy young adults
Acronym A study for of the infection status of Epstein-Barr virus in healthy young adults
Scientific Title A study for of the infection status of Epstein-Barr virus in healthy young adults
Scientific Title:Acronym A study for of the infection status of Epstein-Barr virus in healthy young adults
Region
Japan

Condition
Condition healthy young adults
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will clarify the infection rate of EBV in healthy young adults in Japan. Also, we will measure EBV-DNA load in the peripheral blood of the EBV sero-positive healthy donors.
Basic objectives2 Others
Basic objectives -Others We will investigate the normal bacterial flora in the upper respiratory tract of healthy donors as a control for that of EBV- associated malignancies.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will measure the titers of anti-VCA-IgG and anti-EBNA antibodies in the peripheral blood (whole blood) from healthy donors. Then, we will measure EBV-DNA load of the peripheral blood from the EBV sero-positive donors and determine the cut-off value of the healthy people.
Key secondary outcomes We will identify the bacterial flora of nasal discharge and saliva from the EBV sero-positive donors.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Blood examination for healthy people
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 Students whose written informed consent was obtained.
Tokyo Kasei University: The fourth year-students of Registered Dietitian Major, Department of Food and Nutrition, Faculty of Home Economics.
Tokyo Medical and Dental University: Students of Faculty of Medicine (School of Medicine and School of Health Care Sciences) and Faculty of Dentistry)
The target sample size is 300 and 100 in Tokyo Kasei University and Tokyo Medical and Dental University, respectively.
Key exclusion criteria Students, who are suffering from or have history of EBV-positive neoplasms, will be excluded.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Megumi
Middle name
Last name Sawada
Organization Tokyo Kasei University
Division name Department of Food and Nutrition, Faculty of Home Economics
Zip code 173-8602
Address 1-18-1, Kaga, Itabashi-ku, Tokyo
TEL 03-3961-8092
Email sawada-m@tokyo-kasei.ac.jp

Public contact
Name of contact person
1st name AYAKO
Middle name
Last name ARAI
Organization Tokyo Medical And Dental University
Division name Laboratory Molecular Genetics of Hematology
Zip code 1138519
Address Tokyo
TEL 03-5803-5882
Homepage URL
Email ara.hema@tmd.ac.jp

Sponsor
Institute Japan Agency for Medical Research and development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address Yushima 1-5-45, Bunkyo-ku Tokyo
Tel 0358035882
Email ara.hema@tmd.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 東京家政大学、東京医科歯科大学

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 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
2018 Year 03 Month 22 Day
Date of IRB
2018 Year 04 Month 05 Day
Anticipated trial start date
2018 Year 04 Month 05 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 02 Month 01 Day
Date trial data considered complete
2023 Year 03 Month 01 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2021 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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