ACTRN12610000007033Recruiting未知
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
The Prince Charles Hospital (TPCH)0 sites750 target enrollmentStarted: January 6, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 750
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 60 Years to 75 Years (—)
- Sex
- All
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
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.
Investigators
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