UMIN-CTR Clinical Trial

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
Email	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
Email	ashi@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017548