UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018789 |
|---|---|
| Receipt number | 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 10:10:48 |
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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
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
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Saiseikai Imabari hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
