UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The assessment of predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer in a community-based Study
Title of the study (Brief title)	Predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer
Region	Japan

Condition
Condition	metabolic disease, atherosclerotic disease, and cancer
Classification by specialty	Medicine in general Gastroenterology Cardiology Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify undiagnosed cases of metabolic disease, atherosclerotic disease, and cancer, this study examine the associated factor for diagnosing metabolic disease, atherosclerotic disease, and cancer, and explore the predictive factors for metabolic disease, atherosclerotic disease, and cancer.
Basic objectives2	Others
Basic objectives -Others	usefulness
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Identify associated factor for metabolic disease, atherosclerotic disease, and cancer. 2.Identify predictive factor for metabolic disease, atherosclerotic disease, 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects undergo annual health check-up.
Key exclusion criteria	The subjects with data points missing.
Target sample size	20000

Research contact person
Name of lead principal investigator	Morikazu Onji, Teruki Miyake
Organization	Saiseikai Imabari Hospital
Division name	Internal medicine
Address	Imabari City, Ehime, Japan
TEL	0898472500
Email	m-onji@imabari.saiseikai.or.jp

Public contact
Name of contact person	Teruki Miyake
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
Address	Toon City, Ehime, Japan
TEL	0899605308
Homepage URL
Email	teruki-ygc@umin.ac.jp

Sponsor
Institute	Saiseikai Imabari hospital
Institute
Department

Funding Source
Organization	Saiseikai Imabari Hospital
Organization
Division
Category of Funding Organization	Self funding
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	済生会今治病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 08 Month 01 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	Unpublished
URL releasing results
Results
Other related information	In this community-based study, we eamine the medical records of Japanese subjects (age range, 19-90 years), who undergo annual health checkup. The annual health checkup includes recording the subject's lifestyle habits, medical history, and history of prescribed medication; conducting a physical eamination; and measuring anthropometric and routine biochemica variables. We explore predictive factors for metabolic disease, atherosclerotic disease, and cancer.

Management information
Registered date	2015 Year 08 Month 24 Day
Last modified on	2017 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021735