UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022906
Receipt number 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 14:45:36

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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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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