UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016266
Receipt number R000018819
Scientific Title Risk assessment of lifestyle related diseases by genetic diagnosis
Date of disclosure of the study information 2015/01/21
Last modified on 2017/01/20 14:35:12

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Basic information

Public title

Risk assessment of lifestyle related diseases by genetic diagnosis

Acronym

Risk assessment of lifestyle related diseases by genetic diagnosis

Scientific Title

Risk assessment of lifestyle related diseases by genetic diagnosis

Scientific Title:Acronym

Risk assessment of lifestyle related diseases by genetic diagnosis

Region

Japan


Condition

Condition

Lifestyle related disease

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology
Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate the genetic information and interaction between gene and environment to develop lifestyle related diseases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

development of lifestyle related diseases

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Annual health examination participants of Toyota Motor Co., Ltd. who consented to DNA sampling.

Key exclusion criteria

none

Target sample size

70000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiichi Matsuo

Organization

Nagoya University Graduate school of medicine

Division name

Department of Nephrology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya city

TEL

052-744-2182

Email

smatsuo@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shoichi Maruyama

Organization

Nagoya University Graduate school of medicine

Division name

Department of Nephrology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya city

TEL

052-744-2192

Homepage URL


Email

marus@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Nephrology, Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Toyota Motor Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

2015 Year 01 Month 21 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

Enrolling by invitation

Date of protocol fixation

2011 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 17 Day

Last follow-up date

2017 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data acquisition of health examination, meal-check system, and genetic information associated with lifestyle related diseases.


Management information

Registered date

2015 Year 01 Month 19 Day

Last modified on

2017 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name