Early Detection of Lung Cancer - A Pan Canadian Study
50 Years
75 Years
Both
Lung Cancer, Tobacco Use Disorder
Trial Information
Early Detection of Lung Cancer - A Pan Canadian Study
OBJECTIVES:
- To develop a new multi-modal screening strategy and integrated methods to detect lung
cancer early in current and former smokers.
- To evaluate the impact of the screening modalities on the quality of life of these
participants.
- To develop a decision analytic framework for determining the cost and effectiveness of
a novel lung cancer screening strategy in Canada.
OUTLINE: This is a multicenter study.
Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at
baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm
or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule,
development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3
months. Some participants also undergo autofluorescence and white light bronchoscopy and
bronchial biopsies.
Blood samples are collected at baseline and then annually for 2 years for biomarker studies.
Participants diagnosed with lung cancer undergo additional blood sample collection for
biomarker studies.
Participants complete questionnaires on sociodemographic factors, smoking, occupational
exposure, family history, medical data, quality of life, and anxiety at baseline and then
every 6 months for up to 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Current or former smoker
- A former smoker is defined as one who has stopped smoking ≥ 1 year but < 15
years ago
- Estimated 1-year lung cancer risk ≥ 1%
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant
- Willing to undergo a spiral chest CT scan
- No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
- No acute or chronic respiratory failure
- No bleeding disorder
- No other medical condition that, in the opinion of the investigator, would preclude
the participant's safety during study participation or that would unlikely benefit
the participant from screening due to shortened life expectancy from the co-morbidity
- No diagnosis of cancer, except for any of the following that were previously treated
≥ 5 years ago:
- Non-melanomatous skin cancer
- Localized prostate cancer
- Carcinoma in situ of the cervix
- Superficial bladder cancer
- No known reaction to xylocaine, salbutamol, midazolam, or alfentanil
PRIOR CONCURRENT THERAPY:
- More than 2 years since prior chest CT scan
- No concurrent anti-coagulant treatment (e.g., warfarin or heparin)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Stephen Lam, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
Canada: Ethics Review Committee
Study ID:
CDR0000598586
NCT ID:
NCT00751660
Start Date:
September 2008
Completion Date:
Related Keywords:
- Lung Cancer
- Tobacco Use Disorder
- small cell lung cancer
- non-small cell lung cancer
- tobacco use disorder
- Lung Neoplasms
- Tobacco Use Disorder
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