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Screening Methods in Finding Lung Cancer Early in Current or Former Smokers (Pan Can)

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ClinicalTrials.gov Identifier: NCT00751660
Recruitment Status : Unknown
Verified March 2012 by British Columbia Cancer Agency.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2008
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Tobacco Use Disorder Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: bronchoscopic and lung imaging studies Procedure: computed tomography Procedure: endoscopic biopsy Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2504 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Detection of Lung Cancer - A Pan Canadian Study
Study Start Date : September 2008
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy [ Time Frame: 24 months ]
  2. Number of interval lung cancer cases [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Stage distribution of lung cancer cases [ Time Frame: 60 months ]
  2. Prevalence of lung nodules and differences in geographic distribution across Canada [ Time Frame: 60 months ]
  3. Rate of detection of other incidental significant treatable diseases [ Time Frame: 60 months ]
  4. 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 ]
  5. Potential physical and psychosocial impact on participants [ Time Frame: 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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%


  • 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


  • More than 2 years since prior chest CT scan
  • No concurrent anti-coagulant treatment (e.g., warfarin or heparin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751660

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Canada, Alberta
University of Calgary Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
L'Hopital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
British Columbia Cancer Agency
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Principal Investigator: Stephen Lam, MD British Columbia Cancer Agency
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00751660    
Other Study ID Numbers: CDR0000598586
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012
Keywords provided by British Columbia Cancer Agency:
small cell lung cancer
non-small cell lung cancer
tobacco use disorder
Additional relevant MeSH terms:
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Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders