Lung NeoplasmsNCT02431962
Alberta Lung Cancer Screening Program
A study testing Computed Tomography and Active smokers - Smoking cessation arm in people with Lung Neoplasms and Respiratory Tract Neoplasms, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms, Respiratory Tract Neoplasms
- What is being tested?
- Computed Tomography and Active smokers - Smoking cessation arm
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N4N1
University of Alberta
Edmonton, Alberta
About this study
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.
Read the 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
- Being tested
- Computed Tomography, Active smokers - Smoking cessation arm, Active smokers - Control arm
- Keywords
- Lung Cancer, Screening, Computed Tomography
- Medical subject headings
- Lung Neoplasms, Respiratory Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Low dose chest CT screening annually x 3
Active smokers - Smoking cessation armBehavioural
Phone based smoking cessation counseling
Active smokers - Control armBehavioural
Subjects will be provided with general information on available smoking cessation resources
| Study group | Role | What they receive |
|---|---|---|
| Screening arm | Experimental | Annual low dose screening chest CT scan x 3. Receives: Procedure: Computed Tomography |
| Smoking cessation counseling | Experimental | Active smokers randomized to this arm will be contacted by a trained smoking cessation counselor and offered cessation support and advice. Receives: Behavioral: Active smokers - Smoking cessation arm |
| Smoking cessation control | Active comparator | Active smokers randomized to this arm will receive general information on available smoking cessation resources. Receives: Behavioral: Active smokers - Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria)
The proportion of individuals selected by RPM or NLST will be calculated as the number of subjects qualifying and consenting to the screening intervention / total number of subjects enrolled with either criteria. Superiority of the risk prediction model over NLST criteria will be considered established if it identifies at least as many cases of lung cancer as the NLST while sampling fewer individuals.
Measured: 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])
The primary study endpoint will be an assessment of smoking status at 12 months following randomization. Smoking rates will be assessed via phone questionnaire and abstinence confirmed by saliva nicotine test or exhaled carbon monoxide in subjects using nicotine replacement therapies (to avoid false positive nicotine test).
Measured: 3 years
Secondary outcomes (2)
Evaluation of nodule risk calculator
We will prospectively validate a nodule risk calculator by comparing the proportion of baseline CT examinations reported as positive by the calculator vs. NLST criteria on a per subject basis
Measured: 3 years
Health Economics Analysis (healthcare payer and all direct health-care related cost)
Costs will be estimated for the cohort of individuals who enroll in the screening program and consent to receive a LDCT scan. Costs will also be estimated for a group of individuals who are eligible for the screening program however do not undergo screening. We will include costs for all relevant health care categories for a 2 year period from the date of risk stratification. The perspective of the analysis will be that of the healthcare payer and all direct health-care related costs would be captured and reported in Canadian dollars.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Responsible party
- Principal investigator, Dr. Alain Tremblay, University of Calgary
- Investigators
- Alain Tremblay, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431962
- Sponsor's protocol ID
- 10007170
- Status last verified
- Mar 2021
- First submitted
- 28 Apr 2015
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34589978Tremblay 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.
PubMed 31077790
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alberta Lung Cancer Screening Program
- ClinicalTrials.gov ID
- NCT02431962
- Acronym / sponsor ID
- 10007170
- Conditions
- Lung Neoplasms, Respiratory Tract Neoplasms
- Keywords
- Lung Cancer, Screening, Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Study start
- Apr 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening arm | Experimental | Procedure: Computed TomographyAnnual low dose screening chest CT scan x 3. |
| Smoking cessation counseling | Experimental | Behavioral: Active smokers - Smoking cessation armActive smokers randomized to this arm will be contacted by a trained smoking cessation counselor and offered cessation support and advice. |
| Smoking cessation control | Active comparator | Behavioral: Active smokers - Control armActive smokers randomized to this arm will receive general information on available smoking cessation resources. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyLow dose chest CT screening annually x 3 | Procedure or surgery | Screening arm |
| Active smokers - Smoking cessation armPhone based smoking cessation counseling | Behavioural | Smoking cessation counseling |
| Active smokers - Control armSubjects will be provided with general information on available smoking cessation resources | Behavioural | Smoking cessation control |
Primary outcome
Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria)
Time frame: 5 years
The proportion of individuals selected by RPM or NLST will be calculated as the number of subjects qualifying and consenting to the screening intervention / total number of subjects enrolled with either criteria. Superiority of the risk prediction model over NLST criteria will be considered established if it identifies at least as many cases of lung cancer as the NLST while sampling fewer individuals.
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
The primary study endpoint will be an assessment of smoking status at 12 months following randomization. Smoking rates will be assessed via phone questionnaire and abstinence confirmed by saliva nicotine test or exhaled carbon monoxide in subjects using nicotine replacement therapies (to avoid false positive nicotine test).
2 secondary outcomes
Evaluation of nodule risk calculator
Time frame: 3 years
Health Economics Analysis (healthcare payer and all direct health-care related cost)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 34589978Tremblay 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.
- Derived from this study: PubMed 31077790Tremblay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Tremblay, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography and Active smokers - Smoking cessation arm in people with Lung Neoplasms and Respiratory Tract Neoplasms, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.