UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028954
Receipt number R000033132
Scientific Title Investigation of risk factors for malignant tumor, cardiovascular diseases, and lifestyle related diseases in the health check-up population in Japan.
Date of disclosure of the study information 2017/09/15
Last modified on 2023/09/06 13:18:14

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Basic information

Public title

Investigation of risk factors for malignant tumor, cardiovascular diseases, and lifestyle related diseases in the health check-up population in Japan.

Acronym

NAGOYA Health Check Study (NHC study)

Scientific Title

Investigation of risk factors for malignant tumor, cardiovascular diseases, and lifestyle related diseases in the health check-up population in Japan.

Scientific Title:Acronym

NAGOYA Health Check Study (NHC study)

Region

Japan


Condition

Condition

Cardiovascular diseases, lifestyle related diseases, malignant tumor, arteriosclerosis, etc

Classification by specialty

Not applicable Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the risk factors of malignant tumor, cardiovascular diseases, lifestyle related diseases, and arteriosclerosis using the health check-up data.

Basic objectives2

Others

Basic objectives -Others

To elucidate the high risk population for above mentined diseases based on the prospective or retrospective cohort studies using health check-up data.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of lifestyle related diseases; hypertension, dyslipidemia, metabolic syndrome, CKD.
The incidence of cardiovascular diseases.
The incidence of malignant tumor.

Key secondary outcomes

The signs of arteriosclerosis.


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

Those who underwent health check-up at Kokusai Central Clinic, or Dai-Nagoya-Building Central Clinic after 2010.

Key exclusion criteria

Those who were under 20 year-old at visiting our clinics.
Those who did not agree with this study.

Target sample size

70000


Research contact person

Name of lead principal investigator

1st name Kengo
Middle name
Last name Maeda

Organization

Kokusai Central Clinic
Dai-Nagoya-Building Central Clinic

Division name

Internal Medicine

Zip code

450-0001

Address

1-47-1 Nagono Nakamura-ku Nagoya Aichi

TEL

052-521-0633

Email

maedaken@central-cl.or.jp


Public contact

Name of contact person

1st name Kengo
Middle name
Last name Maeda

Organization

Kokusai Central Clinic

Division name

Internal Medicine

Zip code

450-0001

Address

1-47-1 Nagono Nakamura-ku Nagoya Aichi

TEL

052-521-0633

Homepage URL


Email

maedaken@central-cl.or.jp


Sponsor or person

Institute

Kokusai Central Clinic

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Comittee of Japan Medical Association

Address

2-28-8 Motokomagome Bunkyo-ku Tokyo

Tel

03-5319-3781

Email

rinri@jmacct.med.or.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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

We investigated the relationship between FIB-4 index and prevalent cardiovascular disease and metabolic syndrome. In the individuals with fatty liver detected by ultrasonography, high FIB-4 index was significantly associated with prevalent cardiovascular disease and metabolic syndrome.

Furthermore, in the male working-age participants, hypertension was significantly associated with incident cancer, while this relationship was not observed in the female participants.

Results date posted

2020 Year 03 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures

CVD event
incident hypertension
incident CKD
incident cancer

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 07 Month 18 Day

Date of IRB

2017 Year 08 Month 29 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will conduct the prospective or retrospective observational cohort study using the data of participants who visit our clinics after 2010.
We will analyze the accumulating data yearly, and publish the findings.
We will follow up the participants until Mar 31, 2027.


Management information

Registered date

2017 Year 09 Month 01 Day

Last modified on

2023 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033132


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name