ow dose Computed Tomography (CT) screening for lung cancer
- Conditions
- lung cancerCancer - Lung - Non small cell
- Registration Number
- ACTRN12610000007033
- Lead Sponsor
- The Prince Charles Hospital (TPCH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 750
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
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The CT scans will be examined for the presence of lung nodules and masses suspicious for lung cancer, and other chest abnormalities.<br><br>Nodules will be assessed by monitoring by health care professionals or diagnostic biopsies.[There will be baseline prevalence scan at study entry, and then an incident scan at 12 months for 2 years.<br>The outcomes will be checked at yearly intervals.]
- Secondary Outcome Measures
Name Time Method Quality of Life (QOL) and anxiety will be assessed by questionnaires.[These will be collected at yearly intervals for 2 years and/or after interval scans if needed.];Smoking cessation outcomes will be assessed by questionnaires.[These will be collected at yearly intervals for 2 years.];Costs outcomes will be assessed by questionnaires of medical costs associated with screening.[These will be collected at yearly intervals for 2 years.];Incidental disease will be assessed by health care professional monitoring and data collected by questionnaire.[These will be collected at yearly intervals for 2 years.]