Project Lung Cancer Screening in Southern Denmark (PLUS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Screening by low-dose CT scan

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.

• Study Type: Interventional
• Enrollment (Actual): 1332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Odense University Hospital
    • Svendborg, Region Syddanmark, Denmark, 5700
      • Department of Radiology, Svendborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Low-dose CT scans are performed once a year from 2024 to 2026 to screen for lung cancer including a lung function test the first year of attendance (2024).	Radiation: Screening by low-dose CT scan; Screening for lung cancer by low-dose CT scan
No Intervention: Control; Citizens from the cohort who are randomized to no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold	ratio	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Male/female	Baseline
Height	Centimeters	Baseline
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)
Weight	Kilogram	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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Director: Michael Stenger, Consultant, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: S-20240033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No