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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2504 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Detection of Lung Cancer - A Pan Canadian Study|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||March 2013|
- 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 ]
- 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 ]
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
|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|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Quebec, Canada, G1V 4G5|
|Principal Investigator:||Stephen Lam, MD||British Columbia Cancer Agency|