Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000054617p
Ethics application status
Submitted, not yet approved
Date submitted
13/10/2022
Date registered
17/01/2023
Date last updated
17/01/2023
Date data sharing statement initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chest x-ray versus low dose high resolution computed tomography in screening Queensland workers for occupational dust lung disease.
Scientific title
A study comparing the diagnostic accuracy of the current imaging method for screening of occupational lung diseases in dust-exposed workers (International Labour Organization (ILO) chest x-ray (CXR)) to low-dose high resolution computed tomography (LD HRCT).
Secondary ID [1] 307965 0
Nil known
Universal Trial Number (UTN)
U1111-1282-4807
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occupational Lung Disease 327626 0
Condition category
Condition code
Respiratory 324713 324713 0 0
Other respiratory disorders / diseases
Respiratory 324714 324714 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The research intervention is a single low dose (LD) high resolution computed tomography (HRCT) scan (non-contrast).

The LD HRCT scan will be done in a fully accredited imaging clinic by an accredited radiologist.
There is no dye injection, and no special preparation required.
The scan is performed within a CT scan machine, and takes less than 15 minutes.
The participant will be asked to breathe in and out for different scan images.

The CT scan can be performed on the same day as the workers standard care International Labour Organisation chest x-ray (ILO CXR) or within 3 months of their ILO CXR (to fulfill inclusion criteria).

No further radiological and/or clinical investigation will be undertaken as part of this study.

Intervention code [1] 324425 0
Early Detection / Screening
Comparator / control treatment
Standard care ILO CXR (performed on the same day or within 3 months of the CT scan).
Control group
Active

Outcomes
Primary outcome [1] 332544 0
Diagnostic accuracy assessment of ILO CXR vs LD HRCT in triggering a radiology positive screening result requiring further investigation; defined as, findings leading to an ILO score of >0/1; and/or classifiable pleural disease; and/or identification of emphysema or interstitial fibrosis. Determined by the sensitivity, specificity, positive predictive value of ILO CXR calculated relative to gold standard (CT). These measures will be assessed as a composite primary outcome.
Timepoint [1] 332544 0
Once all the scans are assessed by the thoracic radiologists.
Primary outcome [2] 332561 0
Comparison of accuracy of CXR and LD HRCT in screening workers for clinically relevant disease, the diagnosis of which may be based on radiological and non-radiological assessment. Determined by the sensitivity, specificity, positive predictive value (as a composite primary outcome) of ILO CXR v LD HRCT calculated relative to gold standard of eventual clinical diagnosis of a dust-related lung disease. A dust-related lung disease is defined as one or more of a number of diseases including pneumoconiosis, chronic obstructive pulmonary disease (including emphysema), lung cancer, asbestosis and mesothelioma. These measures will be assessed as a composite primary outcome.
Timepoint [2] 332561 0
6 months after all the scans are assessed by the thoracic radiologists.
Secondary outcome [1] 414262 0
Comparison of diagnostic performance of the ILO CXR vs LD HRCT using different thresholds of positivity on the ILO score triggering a positive screening result. The comparison will be between using an ILO score of 0/1 as a trigger vs the current standard of 1/0. Determined by the sensitivity, specificity, positive predictive value and an overall summary statistic of the area under the receiver operating curve (AUC) for the ILO CXR result binarised (positive/negative) calculated relative to LD HRCT result, reporting on these metrics for the two different thresholds for binarisation. These measures will be assessed as a composite secondary outcome.
Timepoint [1] 414262 0
Once all the scans are assessed by the thoracic radiologists.
Secondary outcome [2] 414263 0
Cohort analysis for eventual clinical diagnosis of disease (both dust-related and non-dust related) identified through the ILO CXR and LD HRCT investigations as a composite secondary outcome. A dust related lung disease is defined as one or more of a number of diseases including pneumoconiosis, chronic obstructive pulmonary disease (including emphysema), lung cancer, asbestosis and mesothelioma. A non dust related disease includes other disease identified through the diagnostic process, which include heart disease, bony trauma, thyroid lesions, liver lesions, kidney lesions and lung infection (pneumonia). The confirmed diagnostic data will be sourced from the patient’s dust screening program records, obtained through their allocated medical practitioner or screening program records (whichever is appropriate). This will be presented as a population cohort report documenting the prevalence of findings and incidence of identifiable disease.
Timepoint [2] 414263 0
6 months after all the scans are assessed by the thoracic radiologists.

Eligibility
Key inclusion criteria
• Minimum of 18 years of age
• Work/have worked in Queensland industry (i.e. coal mine, hard rock mine, quarry and other respirable crystalline silica-exposed work)
• Have at least ten years of occupational dust exposure (coal mine dust or respirable crystalline silica)
• Be undergoing an occupational health assessment that includes an ILO CXR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Engineered stone-exposed stonemasons or history of exposure to engineered stone products
• Patients with an existing diagnosis of coal workers pneumoconiosis or silicosis
• Patients undergoing ILO CXR for ongoing medical management of disease diagnosed or suspected through previous occupational screening assessment
• Patients with a CT chest study obtained and available to review within the preceding 6 months
• Pregnant or breastfeeding mothers

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be undertaken by an external consulting statistician, to ensure independence in analysis, as well as expertise in interpretation of data and application of appropriate tests. Sensitivity, specificity, negative and positive predictive values and AUC will be reported for the ILO CXR modality compared to the LD HRCT, for the primary and secondary endpoints where applicable.
In the subset of workers who undergo further radiological and/or clinical investigation, a direct comparison of ILO CXR and LD HRCT performance in identifying screening positive cases leading to diagnosis will also be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23272 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 38641 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 312232 0
Government body
Name [1] 312232 0
The State of Queensland through the Office of Industrial Relations
Country [1] 312232 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Level 12, 345 George Street, Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 313767 0
None
Name [1] 313767 0
Address [1] 313767 0
Country [1] 313767 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311611 0
The UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 311611 0
PO Box 499 Toowong QLD 4066
Ethics committee country [1] 311611 0
Australia
Date submitted for ethics approval [1] 311611 0
23/08/2022
Approval date [1] 311611 0
Ethics approval number [1] 311611 0

Summary
Brief summary
This study is a comparative study investigating how ILO chest x-ray compares to low dose high resolution computed tomography (LD HRCT) for early diagnosis of occupational lung disease.

As part of this study participants will be asked to undergo a LD HRCT scan, which is new technology using very low levels of radiation.

HRCT scans are better at diagnosing early stage of occupational lung diseases than chest radiography.

This study will answer the question about whether the low radiation dose HRCT scan used in this study picks up more early stage lung diseases such as black lung, emphysema and silicosis.

No Australian evidence has been collected to demonstrate the use the use of LD HRCT in the screening of occupational lung diseases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121710 0
Dr Catherine Jones
Address 121710 0
I-Med Radiology
Level 4, 11 Commercial Road,
Newstead, QLD 4006
Country 121710 0
Australia
Phone 121710 0
+61 07 3371 9588
Fax 121710 0
Email 121710 0
Catherine.Jones@i-med.com.au
Contact person for public queries
Name 121711 0
Dr Katrina Kildey
Address 121711 0
I-MED Radiology
Level 1, 87 Lang Parade
Auchenflower, QLD, 4066
Country 121711 0
Australia
Phone 121711 0
+61 07 3377 5979
Fax 121711 0
Email 121711 0
katrina.kildey@i-med.com.au
Contact person for scientific queries
Name 121712 0
Dr Catherine Jones
Address 121712 0
I-Med Radiology
Level 4, 11 Commercial Road,
Newstead, QLD 4006
Country 121712 0
Australia
Phone 121712 0
+61 07 3371 9588
Fax 121712 0
Email 121712 0
Catherine.Jones@i-med.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In our patient information and consent form we only ask for approval for information to be provided to: people with a need to access patient information required for clinical care, or for the purposes of conducting the research as described, by authorised persons only, and while meeting all legal, ethical and policy requirements.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17317Study protocol    384663-(Uploaded-10-10-2022-16-12-58)-Study-related document.docx
17318Informed consent form    384663-(Uploaded-10-10-2022-16-17-36)-Study-related document.docx
17319Ethical approval  katrina.kildey@i-med.com.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.