Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

Not Applicable

• Conditions: Lung Cancer; Tobacco Use Disorder

• Registration Number: NCT00751660
• Lead Sponsor: 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.

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2504

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy	24 months
Number of interval lung cancer cases	60 months

Secondary Outcome Measures

Name	Time	Method
Stage distribution of lung cancer cases	60 months
Prevalence of lung nodules and differences in geographic distribution across Canada	60 months
Rate of detection of other incidental significant treatable diseases	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	60 months
Potential physical and psychosocial impact on participants	60 months

Trial Locations

Locations (6)

University of Calgary Health Sciences Centre; 🇨🇦 Calgary, Alberta, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Margaret and Charles Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

L'Hopital Laval; 🇨🇦 Quebec, Canada