UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023055 |
|---|---|
| Receipt number | R000026572 |
| Scientific Title | Tuberculosis infection survey of international students at Keio University using interferon-gamma release assay |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2023/07/13 20:32:37 |
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Basic information
Public title
Tuberculosis infection survey of international students at Keio University using interferon-gamma release assay
Acronym
Tuberculosis infection survey of international students
Scientific Title
Tuberculosis infection survey of international students at Keio University using interferon-gamma release assay
Scientific Title:Acronym
Tuberculosis infection survey of international students
Region
| Japan |
Condition
Condition
Tuberculosis infection
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to survey tuberculosis (TB) infection among international students at Keio University by using interferon-gamma release assay (IGRA), as this information may be useful for TB control at Keio University and TB countermeasures in Japan.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TB infection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
International students at Keio University who can understand the research information and the informed consent form in Japanese and consent voluntarily to participate as a participant in this study.
Key exclusion criteria
International students at Keio University who do not consent voluntarily to participate as a participant in this study.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Nishimura |
Organization
Keio University
Division name
Health Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
tnishimura@keio.jp
Public contact
Name of contact person
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Nishimura |
Organization
Keio University
Division name
Health Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
tnishimura@keio.jp
Sponsor or person
Institute
Keio University
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
Center for Infectious Diseases and Infection Control, Keio University School of Medicine
Research Institute of Tuberculosis, Japan Anti-tuberculosis Association
Name of secondary funder(s)
Keio University
IRB Contact (For public release)
Organization
Institutional Review Board, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20160080
Org. issuing International ID_1
Institutional Review Board, Keio University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
209
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We take blood from the participants and then test these blood samples using IGRA. We evaluate the overall picture of TB infection among international students at Keio University based on the results of the IGRA and a health checkup, as well as the answers on the questionnaire of the participants.
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026572
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
