UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015082 |
|---|---|
| Receipt number | R000017548 |
| Scientific Title | The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis. |
| Date of disclosure of the study information | 2014/10/20 |
| Last modified on | 2021/10/22 11:17:30 |
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Basic information
Public title
The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
Acronym
The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
Scientific Title
The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
Scientific Title:Acronym
The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
Region
| Japan |
Condition
Condition
Dust exposed workers in medical checkup for pneumoconiosis
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ultra-low dose CT (one-to-fifty of conventional dose) in addition to conventional dose CT are performed in medical checkup for pneumoconiosis in dust exposed workers, and we compare the diagnostic performance of radiologists between them to verify the usefulness of ultra-low dose CT scan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of radiologists using the ultra-low-dose CT image and the normal dose CT images on Pneumoconiosis.(Thenon-inferiority to the normal dose CT images of ultra-low-dose CT images.)
Key secondary outcomes
Computer analysis of ultra-low-dose CT image and the normal dose CT image.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After obtaining informed consent, ultra-low dose CT (one-to-fifty of conventional dose) in addition to conventional dose CT are performed.
The database of both images obtained is used for observer study, quantification of the image interpretation and computer analysis.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Dust exposed workers in medical checkup for pneumoconiosis by CT
2.Examinees from 40 years or older to 80 years in obtaining informed consent
3.After receiving a sufficient explanation on participation in this study, Examinees on a through understanding and with the document of voluntary consent
Key exclusion criteria
1.History of surgery in respiratory disease
2.Examinees with severe respiratory diseases except for pneumoconiosis
3.Patients in which principal investigator has determined to be inappropriate as a subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Ashizawa |
Organization
Nagasaki University Hospital
Division name
Clinical Oncology Center
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
098-819-7572
ashi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Ashizawa |
Organization
Nagasaki University Hospital
Division name
Clinical Oncology Center
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
098-819-7572
Homepage URL
ashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
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
Address
Tel
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
岡山労災病院
獨協医科大学病院
北海道中央労災病院
岡山大学病院
滋賀医科大学附属病院
徳島大学大学院
天理よろず相談所病院
東京大学大学院
三菱重工長崎造船所病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 20 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | 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
Management information
Registered date
| 2014 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017548
