UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032099 |
|---|---|
| Receipt number | 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 | 2023/02/25 09:29:39 |
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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
sawada-m@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | MIWAKO |
| Middle name | |
| Last name | NISHIO |
Organization
Tokyo Medical And Dental University
Division name
Laboratory Molecular Genetics of Hematology
Zip code
1138519
Address
Tokyo
TEL
03-5803-5882
Homepage URL
mnishio.lmg@tmd.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and development
Institute
Department
Personal name
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
mnishio.lmg@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、聖マリアンナ医科大学
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
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036624
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| Registered date | File name |
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