UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036267 |
|---|---|
| Receipt number | 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 18:20:02 |
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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
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
takemi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Japan Science & Technology Agency
Institute
Department
Personal name
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
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
Value
https://center6.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 |
