Alberta Lung Cancer Screening Program

NCT ID: NCT02431962

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening arm

Annual low dose screening chest CT scan x 3.

Group Type: EXPERIMENTAL

Computed Tomography

Intervention Type: PROCEDURE

Low dose chest CT screening annually x 3

Smoking cessation counseling

Active smokers randomized to this arm will be contacted by a trained smoking cessation counselor and offered cessation support and advice.

Group Type: EXPERIMENTAL

Active smokers - Smoking cessation arm

Intervention Type: BEHAVIORAL

Phone based smoking cessation counseling

Smoking cessation control

Active smokers randomized to this arm will receive general information on available smoking cessation resources.

Group Type: ACTIVE_COMPARATOR

Active smokers - Control arm

Intervention Type: BEHAVIORAL

Subjects will be provided with general information on available smoking cessation resources

Interventions

Computed Tomography

Low dose chest CT screening annually x 3

Intervention Type: PROCEDURE

Active smokers - Smoking cessation arm

Phone based smoking cessation counseling

Intervention Type: BEHAVIORAL

Active smokers - Control arm

Subjects will be provided with general information on available smoking cessation resources

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjects between the ages of 55 and 80 with a risk prediction model (RPM) ≥1.5% (≥ 1.5% risk of lung cancer over 6 years) OR NLST criteria (age 55-74; ≥ 30 pack-year smoking history; ongoing smoking or quit within 15 years).
• Ability to provide informed consent and participate in study procedures.

Exclusion Criteria

• Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), severe lung disease or lung disease requiring supplemental oxygen that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities or inability to tolerate diagnosis and treatment of a screen detected abnormality. European Cooperative Oncology Group performance status > 2.
• History of lung cancer.
• Have had other cancer or treatment for cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer, localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended > 6 months before registration into this study.
• Pregnancy.
• Hemoptysis in past 12 months.
• Unexplained weight loss >15 pounds / 7kg in past 12 months.
• Unwilling to have a LDCT of chest.
• Unwilling to sign a consent.
• Have had a CT scan of the chest in the last 2 years.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alberta Cancer Foundation

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alain Tremblay

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alain Tremblay, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

Tremblay A, Taghizadeh N, MacEachern P, Burrowes P, Graham AJ, Lam SC, Yang H, Koetzler R, Tammemagi MC, Taylor K, Bedard ELR. Two-Year Follow-Up of a Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. JTO Clin Res Rep. 2020 Sep 15;2(2):100097. doi: 10.1016/j.jtocrr.2020.100097. eCollection 2021 Feb.

Reference Type: DERIVED

PMID: 34589978 (View on PubMed)

Tremblay A, Taghizadeh N, Huang J, Kasowski D, MacEachern P, Burrowes P, Graham AJ, Dickinson JA, Lam SC, Yang H, Koetzler R, Tammemagi M, Taylor K, Bedard ELR. A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. J Thorac Oncol. 2019 Sep;14(9):1528-1537. doi: 10.1016/j.jtho.2019.04.024. Epub 2019 May 8.

Reference Type: DERIVED

PMID: 31077790 (View on PubMed)

Other Identifiers

10007170

Identifier Type: -

Identifier Source: org_study_id