UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Tianjin Chronic Low-grade Systemic Inflammation and Health Cohort Study
Title of the study (Brief title)	TCLSIH or TCLSIHealth
Region	Asia(except Japan)

Condition
Condition	cardiovascular diseases and cancer
Classification by specialty	Medicine in general Cardiology Geriatrics Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The study was focused on the relationship between chronic low-grade systemic inflammation and the health status.
Basic objectives2	Others
Basic objectives -Others	lifestyles and chronic diseases prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of cardiovascular diseases and cancer
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants, who had received health examinations and had completed questionnaires regarding their lifestyles.
Key exclusion criteria	cardiovascular diseases and cancer
Target sample size	100000

Research contact person
Name of lead principal investigator	Kaijun Niu
Organization	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.
Division name	Nutritional Epidemiology Institute
Address	22 Qixiangtai Road, Heping District, Tianjin 300070, China.
TEL	+86-22-83336613
Email	nkj0809@gmail.com

Public contact
Name of contact person	Kaijun Niu
Organization	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin,
Division name	Nutritional Epidemiology Institute
Address	22 Qixiangtai Road, Heping District, Tianjin 300070, China.
TEL	+86-22-83336613
Homepage URL
Email	nkj0809@gmail.com

Sponsor
Institute	Tianjin Medical University, Tianjin, China.
Institute
Department

Funding Source
Organization	National Natural Science Foundation of China
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	There were 50,000 participants who had received at least one health examination.

Management information
Registered date	2017 Year 04 Month 28 Day
Last modified on	2017 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031137