This trial is active, not recruiting.

Conditions lung cancer, tobacco use disorder
Treatments laboratory biomarker analysis, screening questionnaire administration, bronchoscopic and lung imaging studies, computed tomography, endoscopic biopsy, quality-of-life assessment
Sponsor British Columbia Cancer Agency
Start date September 2008
End date March 2013
Trial size 2504 participants
Trial identifier NCT00751660, BCCA-H08-01132, CDR0000598586


RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening

Primary Outcomes

Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
time frame: 24 months
Number of interval lung cancer cases
time frame: 60 months

Secondary Outcomes

Stage distribution of lung cancer cases
time frame: 60 months
Prevalence of lung nodules and differences in geographic distribution across Canada
time frame: 60 months
Rate of detection of other incidental significant treatable diseases
time frame: 60 months
Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not
time frame: 60 months
Potential physical and psychosocial impact on participants
time frame: 60 months

Eligibility Criteria

Male or female participants from 50 years up to 75 years old.

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)

Additional Information

Official title Early Detection of Lung Cancer - A Pan Canadian Study
Principal investigator Stephen Lam, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by British Columbia Cancer Agency.