Clinical trial NCT06537804: Project Lung Cancer Screening in Southern Denmark
Official title: Project Lung Cancer Screening in Southern Denmark
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 1332
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Heavy smokers (≥ 30 pack years) or citizens with a PLCOm2012 calculated 6-year risk of lung cancer \> 2%.
* Age: 60-74 years old
* Residence on Funen and surrounding islands

Exclusion Criteria:

* Cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months
* CT scan performed within the past 12 months

Primary outcomes:
measure: Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold
timeFrame: Up to 36 months
Secondary outcomes:
measure: Characteristics of citizens from the cohort based on registry data
timeFrame: Up to 36 months
measure: Participation rate
timeFrame: 36 months (complete study period)
measure: Dropouts
timeFrame: 36 months (complete study period)
measure: Lung cancer found on low dose CT-scans
timeFrame: Baseline, after 1 year, after 2 years
measure: Inconclusive or non-malignant findings on low dose CT scans
timeFrame: Baseline, after 1 year, after 2 years
measure: FEV1
timeFrame: Baseline
measure: FVC
timeFrame: Baseline
measure: Treatment diagnose - cancer
timeFrame: 36 months (complete study period)
measure: Hospitalization time
timeFrame: 36 months (complete study period)
measure: Treatment diagnose - any other disease (found on low dose CT scans)
timeFrame: 36 months (complete study period)
measure: Referral to follow-up procedures
timeFrame: 36 months Entire study period
measure: Self reported health and quality of life assessed by the EQ-5D-5L questionnair
timeFrame: Baseline and after 2 years
measure: Self-reported smoking status
timeFrame: Baseline, after 1 year, after 2 years
measure: All-cause-mortality
timeFrame: 36 months (the entire study period)
measure: Gender
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Smoking history
timeFrame: baseline
measure: Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases
timeFrame: 36 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syddanmark
city: Svendborg
country: Denmark
facility: Department of Radiology, Svendborg Hospital
state: Region Syddanmark
Study officials:
affiliation: Odense University Hospital
name: Michael Stenger, Consultant
role: STUDY_DIRECTOR
References: