UMIN-CTR Clinical Trial

Basic information
Public title	Investigation and research on disaster-related diseases in the Kumamoto earthquake (Aso district)
Acronym	Research on disaster-related diseases (Aso district)
Scientific Title	Investigation and research on disaster-related diseases in the Kumamoto earthquake (Aso district)
Scientific Title:Acronym	Research on disaster-related diseases (Aso district)
Region	Japan

Condition
Condition	disaster-related(Cardiovascular disease,Digestive disorders)
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Cardiology Emergency medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understanding disaster-related diseases in disaster-stricken areas (Aso district)
Basic objectives2	Others
Basic objectives -Others	Reduction of disaster-related death
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in disaster-related diseases in the Aso area up to three years after the Kumamoto earthquake
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents in the affected area
Key exclusion criteria	Those who can not obtain consent
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Yamamura
Organization	Faculty of Medical Science, University of Fukui
Division name	Deparement of Community Medicine
Zip code	910-1193
Address	23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL	0776-61-3111
Email	kapi@u-fukui.ac.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Yamamura
Organization	Faculty of Medical Science, University of Fukui
Division name	Deparement of Community Medicine
Zip code	910-1193
Address	23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL	0776-61-3111
Homepage URL
Email	kapi@u-fukui.ac.jp

Sponsor
Institute	Faculty of Medical Science, University of Fukui
Institute
Department

Funding Source
Organization	Faculty of Medical Science, University of Fukui
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukui University School of Medicine Ethics Committee
Address	23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel	0776-61-8529
Email	chiken@ml.u-fukui.ac.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	2020 Year 02 Month 06 Day

Related information
URL releasing protocol	No URL
Publication of results	Partially published

Result
URL related to results and publications	No URL
Number of participants that the trial has enrolled	390
Results	1. The deep vein thrombosis detection rate was long-term high from the evacuation stage. 2. A rare disease, a localized subclavian artery, was detected.
Results date posted	2020 Year 02 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Victims (Minami Aso Village, Aso City, Nishihara Village)
Participant flow	Excludes those with incomplete questionnaire
Adverse events	None
Outcome measures	Evaluation of disaster-related diseases
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 01 Day
Date of IRB	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Descriptive epidemiology research Case control study Cross-sectional research

Management information
Registered date	2020 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044934