Project Lung Cancer Screening in Southern Denmark
NCT Number: NCT06537804
Acronym: PLUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: RADIATION: Screening by low-dose CT scan
Sponsor: Odense University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-02
Completion Date: 2026-12-31

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.

Primary Outcome Measures: Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold, ratio, Up to 36 months
Secondary Outcome Measures: Characteristics of citizens from the cohort based on registry data, Registry data, Up to 36 months|Participation rate, Number and percentage of citizens completing the screening trial, 36 months (complete study period)|Dropouts, Number and percentage of citizens included that dropout during the study period, 36 months (complete study period)|Lung cancer found on low dose CT-scans, Number and percentage, Baseline, after 1 year, after 2 years|Inconclusive or non-malignant findings on low dose CT scans, Number and percentage, Baseline, after 1 year, after 2 years|FEV1, Measured in liters by a lung function test, Baseline|FVC, Measured in liters by a lung function test, Baseline|Treatment diagnose - cancer, number and percentage of treatments by action diagnosis related to cancer, 36 months (complete study period)|Hospitalization time, Hospitalization time related to lung cancer diagnosis measures in days, 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), 36 months (complete study period)|Referral to follow-up procedures, Number of referrals, 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", Baseline and after 2 years|Self-reported smoking status, Yes/no/former smoker, Baseline, after 1 year, after 2 years|All-cause-mortality, Number of deaths in both groups (intervention/no intervention), 36 months (the entire study period)|Gender, Male/female, Baseline|Weight, Kilogram, Baseline|Height, Centimeters, Baseline|Smoking history, according to the PLCOm2012 risk model, baseline|Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases, hours, 36 months