Alberta Lung Cancer Screening Program

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02431962
• Date of registration: 28/04/2015
• Prospective Registration: No
• Primary sponsor: University of Calgary
• Public title: Alberta Lung Cancer Screening Program
• Scientific title: Alberta Lung Cancer Screening Program
• Date of first enrolment: April 2015
• Target sample size: 800
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02431962
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Alain Tremblay, MD
• Affiliation: University of Calgary

Key inclusion & exclusion 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.



Age minimum: 55 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lung Neoplasms

Respiratory Tract Neoplasms

Intervention(s)

Procedure: Computed Tomography

Behavioral: Active smokers - Smoking cessation arm

Behavioral: Active smokers - Control arm

Primary Outcome(s)

Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria) [Time Frame: 5 years]

Randomized trial of smoking cessation intervention in screened individuals (smoking status [smoking rates assessed via questionnaire and abstinence confirmed by saliva nicotine or exhaled carbon minoxide]) [Time Frame: 3 years]

Secondary Outcome(s)

Health Economics Analysis (healthcare payer and all direct health-care related cost) [Time Frame: 4 years]

Evaluation of nodule risk calculator [Time Frame: 3 years]

Secondary ID(s)

10007170

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alberta Cancer Foundation