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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015082 |
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Date of registration:
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20/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
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Scientific title:
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The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis. - The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis. |
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Date of first enrolment:
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2014/10/20 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017548 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuto Ashizawa |
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Address:
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1-7-1 Sakamoto,Nagasaki
Japan |
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Telephone:
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098-819-7572 |
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Email:
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ashi@nagasaki-u.ac.jp |
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Affiliation:
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Nagasaki University Hospital Clinical Oncology Center |
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Name:
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Kazuto Ashizawa |
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Address:
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1-7-1 Sakamoto,Nagasaki
Japan |
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Telephone:
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098-819-7572 |
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Email:
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ashi@nagasaki-u.ac.jp |
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Affiliation:
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Nagasaki University Hospital Clinical Oncology Center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
40years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Dust exposed workers in medical checkup for pneumoconiosis
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Intervention(s)
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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.
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Primary Outcome(s)
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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.)
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Secondary Outcome(s)
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Computer analysis of ultra-low-dose CT image and the normal dose CT image.
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Source(s) of Monetary Support
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Health Labour Sciences Research Grant
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Ethics review
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Status: YES
Approval date: 29/07/2014
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2020 |
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URL:
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