Lung Cancer Screening Clinical Trial
Official title:
Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland
Verified date | October 2023 |
Source | Oulu University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility | Inclusion Criteria: - Able to provide written informed consent - Age between 50-74 - Smoked = 15 cigarettes/day for = 25 years or smoked = 10 cigarettes/day for = 30 years and are active smokers (smoking during the last two weeks) - Access to a smartphone (iPhone or Android) Exclusion Criteria: - A moderate or bad self-reported health; e.g. unable to climb two flights of stairs - Body weight = 140 kilogram - Current or past melanoma, lung, renal or breast cancer - A chest CT examination less than one year before inclusion - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Subject is unwilling or unable to comply with treatment and trial instructions - Any condition that study investigators consider an impediment to safe trial participation |
Country | Name | City | State |
---|---|---|---|
Finland | Oulu University Hospital | Oulu | |
Finland | Vaasa Central Hospital | Vaasa |
Lead Sponsor | Collaborator |
---|---|
Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of active smokers at 3 months | The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms | 3 months | |
Secondary | Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months | The percentage of subjects who have reduced the amount of smoked cigrattes/d at 3 months after inclusion compared to between the study arms | 3 months | |
Secondary | Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months | The percentage of subjects who have reduced the amount of smoked cigrattes/d at 6 months after inclusion compared to baseline between the study arms | 6 months | |
Secondary | The reduction in number of smoked cigarettes/d at 3 months | Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. | 3 months | |
Secondary | The reduction in number of smoked cigarettes/d at 6 months | Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. | 6 months | |
Secondary | The percentage of reduction in number of smoked cigarettes/d at 3 months | Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. | 3 months | |
Secondary | The percentage of reduction in number of smoked cigarettes/d at 6 months | Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. | 6 months | |
Secondary | Sensitivity of CT screening in the whole cohort | The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer. | At 2 years | |
Secondary | Costs related to CT screening including additional investigations | The cumulative cost of diagnostic investigations per study subject. | At 2 years |
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