NCT02431962

Alberta Lung Cancer Screening Program

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Lung cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. Yet endorsement of lung cancer screening has not been universal because of outstanding concerns which need to be addressed. Our study will aim to screen at risk Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to fill some knowledge gaps on this topic.

Detailed description

Lung cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Lung cancer incidence and mortality rates are similar because lung cancer is a highly fatal disease. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. The results of the National Lung Screening Trial (NLST) showed a 20% reduction in mortality from lung cancer with LDCT screening in addition to a 6.7% decrease in all-cause mortality, the first ever screening intervention to demonstrate an improvement in this latter outcome. Yet endorsement of lung cancer screening has not been universal. Although the NLST results are encouraging, more investigation is needed. The objectives of this study are to prospectively compare the performance of a lung cancer risk prediction model (RPM) vs. NLST criteria to inform optimal inclusion criteria for a clinical screening program; to prospectively compare a novel screening based nodule malignancy probability calculation which has been developed in the Pan-Canadian Early Detection of Lung Cancer study vs. NLST criteria; to complete a randomized controlled trial as a substudy comparing an intensive tobacco cessation counseling program to a usual care arm for subjects with ongoing tobacco use; to perform a cost analysis evaluating the incremental costs associated with LDCT screening for lung cancer compared to no screening; to determine the average cost associated with incidental findings, false positive findings and lung cancers found during the screening period; and to compare cost implications of both screening enrollment criteria. The backbone of this research project will be the screening of at risk individuals for lung cancer with LDCT scan. Eight hundred at risk Albertans will be screened at baseline, year 1 and year 2. Additional clinical LDCT or other investigations may result from findings on the study CT scans.

Conditions

• Lung Neoplasms
• Respiratory Tract Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Low dose chest CT screening annually x 3
BEHAVIORAL	Active smokers - Smoking cessation arm	Phone based smoking cessation counseling
BEHAVIORAL	Active smokers - Control arm	Subjects will be provided with general information on available smoking cessation resources

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2015-05-01
• Last updated: 2021-03-08

Locations

2 sites across 1 country: Canada