One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.
This pilot study is a prospective interventional feasibility study. The primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in Denmark (current or former heavy smokers). The pilot study will be performed on Funen in the Region of Southern Denmark and will run over three years (2024-2026). One thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual LDCT scans for three consecutive years. Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
Screening for lung cancer by low-dose CT scan
Odense University Hospital
Odense, Region Syddanmark, Denmark
Department of Radiology, Svendborg Hospital
Svendborg, Region Syddanmark, Denmark
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold
ratio
Time frame: Up to 36 months
Characteristics of citizens from the cohort based on registry data
Registry data
Time frame: Up to 36 months
Participation rate
Number and percentage of citizens completing the screening trial
Time frame: 36 months (complete study period)
Dropouts
Number and percentage of citizens included that dropout during the study period
Time frame: 36 months (complete study period)
Lung cancer found on low dose CT-scans
Number and percentage
Time frame: Baseline, after 1 year, after 2 years
Inconclusive or non-malignant findings on low dose CT scans
Number and percentage
Time frame: Baseline, after 1 year, after 2 years
FEV1
Measured in liters by a lung function test
Time frame: Baseline
FVC
Measured in liters by a lung function test
Time frame: Baseline
Treatment diagnose - cancer
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NONE
Enrollment
1,332
number and percentage of treatments by action diagnosis related to cancer
Time frame: 36 months (complete study period)
Hospitalization time
Hospitalization time related to lung cancer diagnosis measures in days
Time frame: 36 months (complete study period)
Treatment diagnose - any other disease (found on low dose CT scans)
number and percentage of treatment diagnosis related to findings of other diseases (by action diagnosis)
Time frame: 36 months (complete study period)
Referral to follow-up procedures
Number of referrals
Time frame: 36 months Entire study period
Self reported health and quality of life assessed by the EQ-5D-5L questionnair
level of percieved problems are coded from level 1 to 5 in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression"
Time frame: Baseline and after 2 years
Self-reported smoking status
Yes/no/former smoker
Time frame: Baseline, after 1 year, after 2 years
All-cause-mortality
Number of deaths in both groups (intervention/no intervention)
Time frame: 36 months (the entire study period)
Gender
Male/female
Time frame: Baseline
Weight
Kilogram
Time frame: Baseline
Height
Centimeters
Time frame: Baseline
Smoking history
according to the PLCOm2012 risk model
Time frame: baseline
Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases
hours
Time frame: 36 months