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Note: This record shows only 21 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.
Register: JPRN
Last refreshed on: 21 July 2016
Main ID:  JPRN-UMIN000015082
Date of registration: 20/10/2014
Prospective Registration: Yes
Primary sponsor: Nagasaki University Hospital
Public title: The observational study by CT on technique and diagnostic criteria of the Pneumoconiosis.
Scientific title:
Date of first enrolment: 2014/10/20
Target sample size: 50
Recruitment status: Open public recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017548
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Kazuto Ashizawa   
Address:  1-7-1 Sakamoto,Nagasaki Japan
Telephone: 098-819-7572
Email: ashi@nagasaki-u.ac.jp
Affiliation:  Nagasaki University Hospital Clinical Oncology Center
Key inclusion & exclusion criteria
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

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
Health Condition(s) or Problem(s) studied
Dust exposed workers in medical checkup for pneumoconiosis
Intervention(s)
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.
Primary Outcome(s)
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.)
Secondary Outcome(s)
Computer analysis of ultra-low-dose CT image and the normal dose CT image.
Secondary ID(s)
Source(s) of Monetary Support
Health Labour Sciences Research Grant
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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