Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000007033
Ethics application status
Approved
Date submitted
29/12/2008
Date registered
6/01/2010
Date last updated
6/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low dose Computed Tomography (CT) screening for lung cancer
Scientific title
Queensland Lung Cancer Screening Study - An observational cohort study of low dose computerised tomography (CT) scans; feasibility, lung nodule detection rate, lung cancer detection rate, quality of life, anxiety, smoking cessation and costs in people at high risk for lung cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 3813 0
Condition category
Condition code
Cancer 3995 3995 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Low dose CT with multi-detector CT to detect pulmonary nodules and lung cancer in people at high risk of having lung cancer.

This uses a lower than usual dose of CT scanning than conventional CT chest doses to reduce radiation exposure.
The condition that is being screened for is lung cancer.
There will be one low-dose CT screening scan per year for 3 years, with follow up taking an additional 3 years after the last scan.
Intervention code [1] 3533 0
Not applicable
Intervention code [2] 255757 0
Early detection / Screening
Comparator / control treatment
Observational
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4899 0
The CT scans will be examined for the presence of lung nodules and masses suspicious for lung cancer, and other chest abnormalities.

Nodules will be assessed by monitoring by health care professionals or diagnostic biopsies.
Timepoint [1] 4899 0
There will be baseline prevalence scan at study entry, and then an incident scan at 12 months for 2 years.
The outcomes will be checked at yearly intervals.
Secondary outcome [1] 8274 0
Quality of Life (QOL) and anxiety will be assessed by questionnaires.
Timepoint [1] 8274 0
These will be collected at yearly intervals for 2 years and/or after interval scans if needed.
Secondary outcome [2] 262782 0
Smoking cessation outcomes will be assessed by questionnaires.
Timepoint [2] 262782 0
These will be collected at yearly intervals for 2 years.
Secondary outcome [3] 262783 0
Costs outcomes will be assessed by questionnaires of medical costs associated with screening.
Timepoint [3] 262783 0
These will be collected at yearly intervals for 2 years.
Secondary outcome [4] 262784 0
Incidental disease will be assessed by health care professional monitoring and data collected by questionnaire.
Timepoint [4] 262784 0
These will be collected at yearly intervals for 2 years.

Eligibility
Key inclusion criteria
- Age 60 -74 years and 364 days.
- Current or previous cumulative cigarette smoking history of > 30 pack years (packs per day multiplied by the number of years smoked). Former smokers must have quit smoking within the previous 15 years.
- With or without asbestos exposure
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are intended to eliminate from consideration individuals unable to give informed consent or who, by virtue of medical disability, would unlikely survive to the end of the trial period.

Also excluded are individuals unlikely to complete curative lung cancer surgery (e.g., thoracotomy with lobectomy or pneumonectomy – i.e. poor lung function), individuals presenting with symptoms suggestive of lung cancer; individuals who have had recent chest imaging; or those with physical conditions that would preclude high quality screening computerised tomography (CT).

Other exclusion criteria are:
- Inability to lie on the back with arms raised above the head. Supine positioning, with or without the support of pillows under the head or extremities, with arms briefly resting above the head, is required for purposes of acquiring helical CT scans.
- Metallic implants or metallic devices in the chest or back (pacemakers or Harrington fixation rods, etc.) that would cause sufficient beam hardening artefact so as to degrade image quality in the lungs.
- Prior history of lung cancer.
- Computed Tomography (CT)) of the chest within the past 18 months
- Treatment for, or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
- Prior removal of any portion of the lung, excluding percutaneous lung biopsy.
- Requirement for home oxygen supplementation for respiratory conditions.
- Participation in another cancer screening trial
- Participation in a cancer prevention trial other than smoking cessation programs.
- Present symptoms suggestive of lung cancer, including unexplained weight loss of over 15 lbs (~6.5 kgs) within the past 12 months, or unexplained haemoptysis.
- Any medical condition that poses a significant risk of mortality during the 6-year trial period.
- Any medical or psychiatric condition precluding informed medical consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3995 0
Government body
Name [1] 3995 0
National Center for Asbestos Related Disease (NCARD)
Country [1] 3995 0
Australia
Funding source category [2] 256218 0
Government body
Name [2] 256218 0
Queensland Smart State
Country [2] 256218 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital (TPCH)
Address
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland
Brisbane 4032
Country
Australia
Secondary sponsor category [1] 3586 0
None
Name [1] 3586 0
Address [1] 3586 0
Country [1] 3586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6073 0
The Prince Charles Hospital
Ethics committee address [1] 6073 0
Ethics committee country [1] 6073 0
Australia
Date submitted for ethics approval [1] 6073 0
08/10/2007
Approval date [1] 6073 0
14/11/2007
Ethics approval number [1] 6073 0
2753

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29025 0
Address 29025 0
Country 29025 0
Phone 29025 0
Fax 29025 0
Email 29025 0
Contact person for public queries
Name 12182 0
Queensland Lung Cancer Screening Study Research Officer
Address 12182 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland
Brisbane 4032
Country 12182 0
Australia
Phone 12182 0
+617 3139 4000
Fax 12182 0
Email 12182 0
[email protected]
Contact person for scientific queries
Name 3110 0
Kwun M Fong
Address 3110 0
The Prince Charles Hospital
Rode Road
Chermside
Brisbane
Queensland
4032
Country 3110 0
Australia
Phone 3110 0
+617 3139 4000
Fax 3110 0
+617 3139 4510
Email 3110 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of different radiological models on diagnostic accuracy and lung cancer screening performance.2017https://dx.doi.org/10.1136/thoraxjnl-2016-209624
EmbaseInterstitial lung abnormalities in the Queensland Lung Cancer Screening Study: prevalence and progression over 2 years of surveillance.2019https://dx.doi.org/10.1111/imj.14148
N.B. These documents automatically identified may not have been verified by the study sponsor.