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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036267
Receipt No. R000041312
Scientific Title Verification of asbestos exposure index in Kurashiki City Mabi district rubble disposal victims
Date of disclosure of the study information 2019/07/01
Last modified on 2020/05/01

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Basic information
Public title Verification of asbestos exposure index in Kurashiki City Mabi district rubble disposal victims
Acronym Verification of asbestos exposure index in Kurashiki City Mabi district rubble disposal victims
Scientific Title Verification of asbestos exposure index in Kurashiki City Mabi district rubble disposal victims
Scientific Title:Acronym Verification of asbestos exposure index in Kurashiki City Mabi district rubble disposal victims
Region
Japan

Condition
Condition rubble disposal victims
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Asbestos exposure verification
Basic objectives2 Others
Basic objectives -Others Verification of mesothelioma onset score
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Researcher Suggested Matching Asbestos Exposure and Mesothelioma Onset Scores
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 Historical
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 After the disaster in Mabi district of Kurashiki city in 2018 West Japan heavy rain, engaged in the rubble disposal regardless of the period and the amount of labor
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 Person who was engaged in rubble processing regardless of the time and the amount of labor after damage in Mabi district of Kurashiki city in 2018 West Japan heavy rain
Key exclusion criteria Person who did not engage in rubble processing even after the disaster in Mabi district of Kurashiki City in 2018 West Japan heavy rain 2018 West Japan heavy rain
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takemi
Middle name
Last name Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code 7010192
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email takemi@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Takemi
Middle name
Last name Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code 7010192
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email takemi@med.kawasaki-m.ac.jp

Sponsor
Institute Japan Science & Technology Agency
Institute
Department

Funding Source
Organization Japan Science & Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kawasaki Medical School and Hospitai Ethics Committee
Address 577 Matsushima, Kurashiki, Okayama
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.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
2019 Year 07 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 Completed
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 06 Month 11 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 01 Month 31 Day
Date analysis concluded
2020 Year 02 Month 15 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 21 Day
Last modified on
2020 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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