UMIN-CTR Clinical Trial

Basic information
Public title	The observational study on annual medical checkup at Mishima town, Onuma-gun, Fukushima
Acronym	The observational study on annual medical checkup at Mishima town
Scientific Title	The observational study on annual medical checkup at Mishima town, Onuma-gun, Fukushima
Scientific Title:Acronym	The observational study on annual medical checkup at Mishima town
Region	Japan

Condition
Condition	ordinary people (people attending the annual medical checkups)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the group with high risk of disease onset such as ischemic heart disease using data of annual medical checkups performed from 2016 to 2019 at Mishima town, Onuma-gun, Fukushima Prefecture. This study will be linked to the further prospective investigation in the future.
Basic objectives2	Others
Basic objectives -Others	To understand and analyze the current situation.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Secular changes of important factors associated with disease onset such as renal function
Key secondary outcomes	Effects of modifiable factors such as smoking hibits

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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents who received annual medical checkups at Mishima town, Onuma-gun, Fukushima Prefecture with free will
Key exclusion criteria	(1) The examinees who expressed the intention not to participate in the research (2) Those who were judged by the researchers as ineligible to participate in this study
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Sato
Organization	Fukushima Prefectural Miyashita Hospital
Division name	Department of Internal Medicine
Zip code	969-7511
Address	1150 Minajiri, Miyashita, Mishima town, Onuma-gun, Fukushima, Japan
TEL	0241-52-2321
Email	miyashita.byouin@pref.fukushima.lg.jp

Public contact
Name of contact person	1st name Ichiro Middle name Last name Morisawa
Organization	Fukushima Prefectural Miyashita Hospital
Division name	Department of Administration
Zip code	969-7511
Address	1150 Minajiri, Miyashita, Mishima town, Onuma-gun, Fukushima, Japan
TEL	0241-52-2321
Homepage URL
Email	miyashita.byouin@pref.fukushima.lg.jp

Sponsor
Institute	Fukushima Prefectural Miyashita Hospital
Institute
Department

Funding Source
Organization	Fukushima Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mishima Town Office
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Prefectural Miyashita Hospital
Address	1150 Minajiri, Miyashita, Mishima town, Onuma-gun, Fukushima, Japan
Tel	0241-52-2321
Email	miyashita.byouin@pref.fukushima.lg.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	2019 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	150
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	Completed
Date of protocol fixation	2019 Year 04 Month 22 Day
Date of IRB	2019 Year 04 Month 22 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is an observational study. We will recruit data of annual medical checkups performed at Mishima town from 2016 to 2019. We will use anonymized data and will not handle personally identifiable information. For these reasons, written informed consent will not be obtained from each examinee. However, we publicize the study by posting a summary of the protocol at the checkup site, Fukushima Prefectural Miyashiya Hospital, and website of Mishima Town Office and Fukushima Prefectural Miyashita Hospital; the notice clearly inform patients of their right to refuse enrolment.

Management information
Registered date	2019 Year 04 Month 28 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041715