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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022906
Receipt No. R000026393
Scientific Title The 2nd study for establishing personalized health care system based on individual genetic risk assessment
Date of disclosure of the study information 2017/01/01
Last modified on 2016/06/27

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Basic information
Public title The 2nd study for establishing personalized health care system based on individual genetic risk assessment
Acronym The 2nd study for health care using individual genetic risk
Scientific Title The 2nd study for establishing personalized health care system based on individual genetic risk assessment
Scientific Title:Acronym The 2nd study for health care using individual genetic risk
Region
Japan

Condition
Condition Noncommunicable diseases
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 In this study, we evaluate preciseness of genetic risks for 30 non-communicable diseases analyzed by tightly-linked SNP markers, and outcome measured by various clinical parameters.
Basic objectives2 Others
Basic objectives -Others Establish personalized health care system based on individual genetic risk assessment
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes In questionnaire obtained at the third visit, answer satisfaction from more than 75% individuals who participated in this study.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Intervention is undertaken by nutrition counselling and education. Improvement is assessed in whom diet control is considered useful, at the third visit scheduled approximately 2 months after the first counselling.
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
95 years-old >
Gender Male and Female
Key inclusion criteria 1. Those who are confident about the significance and limitation of this study.
2. Those who agrees to pay the fee of this program, not being covered by health insurance.
3. Those who can visit Tokyo Medical and Dental University Hospital at least three times.
4. Preferably, those who are practiced smartphone users.
Key exclusion criteria 1) Who are not considered appropriate for this program due to their health conditions.
2) Those who misunderstand the program.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kinya Ishikawa
Organization Tokyo Medical and Dental University
Division name Medical Hospital, The Center for Personalized Medicine for Healthy Aging.
Zip code
Address Bunkyo-ku, Yushima 1-5-45
TEL 03-3813-6111
Email pico.nuro@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name The reception, The Center for Personalized Medicine for Healthy Aging.
Organization Tokyo Medical and Dental University
Division name Medical Hospital, The Center for Personalized Medicine for Healthy Aging.
Zip code
Address Bunkyo-ku, Yushima 1-5-45
TEL 03-5803-4390
Homepage URL http://www.tmd.ac.jp/medhospital/chouju/
Email app.pmha@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization P5 Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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

Management information
Registered date
2016 Year 06 Month 27 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026393

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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