UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016242 |
|---|---|
| Receipt number | R000018847 |
| Scientific Title | Studies for reference intervals of basic laboratory tests and usefulness of ningen dock examination based on long-term follow up study and analysis of ningen dock examination data |
| Date of disclosure of the study information | 2015/01/19 |
| Last modified on | 2019/07/24 14:44:35 |
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Basic information
Public title
Studies for reference intervals of basic laboratory tests and usefulness of ningen dock examination based on long-term follow up study and analysis of ningen dock examination data
Acronym
Studies for reference intervals and usefulness of ningen dock examination
Scientific Title
Studies for reference intervals of basic laboratory tests and usefulness of ningen dock examination based on long-term follow up study and analysis of ningen dock examination data
Scientific Title:Acronym
Studies for reference intervals and usefulness of ningen dock examination
Region
| Japan |
Condition
Condition
Ningen dock examination examinee
Classification by specialty
| Medicine in general | Laboratory medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is a calrifyicartion of usefulness of ningen dock examination.
Basic objectives2
Others
Basic objectives -Others
For the clalification of usefulness of ningen dock examination, firstly reference intervals of laboratoru tests in ningen dock examination will be determined, and secondary,
preventive effect of ningen dock examination against lifestyle-related diseases will be determined by using the data of long-term follow up study of ningen dock examinee.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevention for the onset of lifestyle-related diseases.
Key secondary outcomes
Decrease in cancer onset
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
BMI<25 kg/mxm
non-smoker
alcohol<30g ethanol/day
blood pressure<130/85mmHg
Key exclusion criteria
neither receiving any medication for chronic diseases nor having any history of life-threatening diseases, such as malignancy, cardiovasculkar events or stroke.
Target sample size
1000000
Research contact person
Name of lead principal investigator
| 1st name | Kiyoaki |
| Middle name | |
| Last name | Watanabe |
Organization
Japan Society of Ningen Dock
Division name
Scientific committee
Zip code
102-0075
Address
9-15 Sanbancho Chiyada-ku Tokyo
TEL
03-3265-0079
info@ningen-dock.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Yamakado |
Organization
Japan Society of Ningen Dock
Division name
Scientific committee
Zip code
102-0075
Address
9-15 Sanbancho Chiyoda-kuTokyo
TEL
03-3265-0079
Homepage URL
http://www.ningen-dock.jp/
info@ningen-dock.jp
Sponsor or person
Institute
Japan Society of Ningen Dock
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Ningen Dock
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Natinal Federation of Health Insurance Societies
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Japan Society of Ningen Dock
Address
9-15 Sanbancho Chiyodaku Tokyo Japan
Tel
03-3265-0079
info@ningen-dock.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
全国人間ドック健診施設
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
http://www.ningen-dock.jp
Publication of results
Partially published
Result
URL related to results and publications
http://www.ningen-dock.jp
Number of participants that the trial has enrolled
Results
Reference intervals for basic laboratory tests were determined.
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
Folow-up will be contined 1 yaer after starting observation.
Management information
Registered date
| 2015 | Year | 01 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018847
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
