UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016242
Receipt No. 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 (Ver. 5)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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/
Email info@ningen-dock.jp

Sponsor
Institute Japan Society of Ningen Dock
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018847