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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000045722
Receipt No. 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

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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
Email 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
Email daigakukanri@mbox.pub.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052196

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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