Lung CancerPhase 2NCT02385812
Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma
A Phase 2 study testing Low-dose computed tomography Annual scan x3 and Low-dose computed tomography Baseline scan only in people with Lung Cancer and Mesothelioma, run by University of Calgary at 2 sites in Canada.
Trial summary
Asbestos defines a group of naturally occurring mineral silicate fibers which are easily inhaled, resulting in a variety of diseases of the respiratory system including lung cancer and malignant mesothelioma. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Mesothelioma
- What is being tested?
- Low-dose computed tomography Annual scan x3 and Low-dose computed tomography Baseline scan only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2015to 1 Apr 2022
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 - 80 years (either gender, any ethnic group)
- Documented exposure to asbestos for at least one year, at least 10 years prior to study entry
- 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, solid organ transplant, 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
- Have been previously diagnosed with lung cancer or mesothelioma
- Have had other 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
- CT scan of the chest in the past 2 years
- Unwilling to have a LDCT of chest
- Unwilling to sign a consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta
About this study
Asbestos defines a group of naturally occurring mineral silicate fibers which are easily inhaled, resulting in a variety of diseases of the respiratory system including lung cancer and malignant mesothelioma. Despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. This study aims to develop and implement a low-dose computed tomography (LDCT) screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta.
Read the detailed description
In Canada, lung cancer is the primary cause of cancer mortality above the next three culprits combined (breast, colon and prostate cancer). Cigarette smoking is the most important risk factor in the development of lung cancer. Another population of particular interest in Alberta involves workers with occupational exposure to asbestos as asbestos and tobacco exposure results in a synergistic effect on lung cancer risk. Mesothelioma is a rare cancer of the lining of the lung with poor prognosis of which 80% of cases are believed to be related to asbestos exposure.
Unfortunately, despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. Additional strategies are desperately needed to reduce the morbidity and mortality associated with this disease.
The objectives of this study are to develop and implement a LDCT screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta; to determine participants' motivation and expectations associated with a screening program, their satisfaction with the program, and the psychosocial consequences of the screening program; to determine the accuracy of a lung cancer risk prediction model modified to include asbestos exposure; and to determine the 3-year clinical incidence of lung cancer in asbestos-exposed individuals interested in lung cancer screening but who do not meet minimal risk threshold.
The investigators will offer a combined lung cancer and mesothelioma screening program for 200 Alberta asbestos-exposed workers based on low-dose CT scanning.
- Conditions
- Lung Cancer, Mesothelioma
- Being tested
- Low-dose computed tomography Annual scan x3, Low-dose computed tomography Baseline scan only
- Keywords
- Lung Cancer, Mesothelioma, Asbestos, Screening
- Medical subject headings
- Lung Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomography Annual scan x3Procedure or surgery
Annual scan x3
Low-dose computed tomography Baseline scan onlyProcedure or surgery
Baseline scan only
| Study group | Role | What they receive |
|---|---|---|
| High lung cancer risk | Experimental | Individuals with lung cancer risk >= 1.5% over 6 years Receives: Procedure: Low-dose computed tomography Annual scan x3 |
| Low lung cancer risk | Experimental | Individuals with lung cancer risk <1.5% over 6 years Receives: Procedure: Low-dose computed tomography Baseline scan only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SF-12 quality of life score
Measured: Baseline vs. 14 days post receipt of screen results.
Secondary outcomes (3)
Change in EQ-5D and STAI
Measured: Baseline vs. 14 days post receipt of screen results.
Lung cancer detection rate
Measured: 3 years
Mesothelioma detection rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Why it stopped: Low enrollment through COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Cancer Foundation, Western Canadian Mesothelioma 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
- NCT02385812
- Sponsor's protocol ID
- 10007822
- Status last verified
- May 2022
- First submitted
- 27 Nov 2014
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma
- ClinicalTrials.gov ID
- NCT02385812
- Acronym / sponsor ID
- 10007822
- Conditions
- Lung Cancer, Mesothelioma
- Keywords
- Lung Cancer, Mesothelioma, Asbestos, Screening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment through COVID pandemic
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Cancer Foundation, Western Canadian Mesothelioma Foundation
- Study start
- 1 Jan 2015
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Mar 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.
Asbestos defines a group of naturally occurring mineral silicate fibers which are easily inhaled, resulting in a variety of diseases of the respiratory system including lung cancer and malignant mesothelioma. Despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. This study aims to develop and implement a low-dose computed tomography (LDCT) screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta.
Detailed description
In Canada, lung cancer is the primary cause of cancer mortality above the next three culprits combined (breast, colon and prostate cancer). Cigarette smoking is the most important risk factor in the development of lung cancer. Another population of particular interest in Alberta involves workers with occupational exposure to asbestos as asbestos and tobacco exposure results in a synergistic effect on lung cancer risk. Mesothelioma is a rare cancer of the lining of the lung with poor prognosis of which 80% of cases are believed to be related to asbestos exposure.
Unfortunately, despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. Additional strategies are desperately needed to reduce the morbidity and mortality associated with this disease.
The objectives of this study are to develop and implement a LDCT screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta; to determine participants' motivation and expectations associated with a screening program, their satisfaction with the program, and the psychosocial consequences of the screening program; to determine the accuracy of a lung cancer risk prediction model modified to include asbestos exposure; and to determine the 3-year clinical incidence of lung cancer in asbestos-exposed individuals interested in lung cancer screening but who do not meet minimal risk threshold.
The investigators will offer a combined lung cancer and mesothelioma screening program for 200 Alberta asbestos-exposed workers based on low-dose CT scanning.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High lung cancer risk | Experimental | Procedure: Low-dose computed tomography Annual scan x3Individuals with lung cancer risk >= 1.5% over 6 years |
| Low lung cancer risk | Experimental | Procedure: Low-dose computed tomography Baseline scan onlyIndividuals with lung cancer risk <1.5% over 6 years |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 - 80 years (either gender, any ethnic group)
- Documented exposure to asbestos for at least one year, at least 10 years prior to study entry
- Ability to provide informed consent and participate in study procedures
Key exclusion criteria (7 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, solid organ transplant, 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
- Have been previously diagnosed with lung cancer or mesothelioma
- Have had other 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
- CT scan of the chest in the past 2 years
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 |
|---|---|---|
| Low-dose computed tomography Annual scan x3Annual scan x3 | Procedure or surgery | High lung cancer risk |
| Low-dose computed tomography Baseline scan onlyBaseline scan only | Procedure or surgery | Low lung cancer risk |
Primary outcome
Change in SF-12 quality of life score
Time frame: Baseline vs. 14 days post receipt of screen results.
3 secondary outcomes
Change in EQ-5D and STAI
Time frame: Baseline vs. 14 days post receipt of screen results.
Lung cancer detection rate
Time frame: 3 years
Mesothelioma detection rate
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low enrollment through COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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 Phase 2 study testing Low-dose computed tomography Annual scan x3 and Low-dose computed tomography Baseline scan only in people with Lung Cancer and Mesothelioma, 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 May 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment through COVID pandemic). 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?
Change in SF-12 quality of life score (time frame: Baseline vs. 14 days post receipt of screen results.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2022.