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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018789
Receipt No. R000021735
Scientific Title The assessment of predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer in a community-based Study
Date of disclosure of the study information 2015/08/24
Last modified on 2017/03/26

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Basic information
Public title The assessment of predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer in a community-based Study
Acronym Predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer
Scientific Title The assessment of predictive factor for metabolic disease, atherosclerotic disease, and onset of cancer in a community-based Study
Scientific Title:Acronym 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
1st name
Middle name
Last name Morikazu Onji, Teruki Miyake
Organization Saiseikai Imabari Hospital
Division name Internal medicine
Zip code
Address Imabari City, Ehime, Japan
TEL 0898472500
Email m-onji@imabari.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021735

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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