UMIN-CTR Clinical Trial

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