UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045722 |
|---|---|
| Receipt number | R000052196 |
| Scientific Title | Prospective observational study regarding Japanese employees' health and biomarkers |
| Date of disclosure of the study information | 2021/10/11 |
| Last modified on | 2021/10/11 16:40:23 |
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Basic information
Public title
Prospective observational study regarding Japanese employees' health and biomarkers
Acronym
Prospective observational study regarding Japanese employees' health and biomarkers
Scientific Title
Prospective observational study regarding Japanese employees' health and biomarkers
Scientific Title:Acronym
Prospective observational study regarding Japanese employees' health and biomarkers
Region
| Japan |
Condition
Condition
Japanese Employees
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between psychosocial factors and biomarkers among Japanese employees
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory markers (Interferon (IFN)-gamma, Interleukin (IL)-6, IL-8, Tumor necrosis factor (TNF)-alpha, IL-12/23p40, IL-15, IL-5, IL-27, etc.), C-reactive protein and Conserved Transcriptional Response to Adversity (CTRA)
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
-Employees who work in the company
-Those who agreed to participate
Key exclusion criteria
-Those who withdraw the consent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city
TEL
093-691-7523
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city
TEL
093-691-7523
Homepage URL
daigakukanri@mbox.pub.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee of Medical Research, University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city
Tel
093-691-7205
daigakukanri@mbox.pub.uoeh-u.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 | 10 | Month | 11 | 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
634
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
| 2018 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | 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
Data cleaning is underway.
Management information
Registered date
| 2021 | Year | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052196
