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Active, Not Recruiting

NCT Number: NCT06537804

Project Lung Cancer Screening in Southern Denmark

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Region Syddanmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening by low-dose CT scan

Radiation

Screening for lung cancer by low-dose CT scan

Primary outcomes

  1. Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold

    Time frame: Up to 36 months

    ratio

Secondary outcomes

  1. Characteristics of citizens from the cohort based on registry data

    Time frame: Up to 36 months

    Registry data

  2. Participation rate

    Time frame: 36 months (complete study period)

    Number and percentage of citizens completing the screening trial

  3. Dropouts

    Time frame: 36 months (complete study period)

    Number and percentage of citizens included that dropout during the study period

  4. Lung cancer found on low dose CT-scans

    Time frame: Baseline, after 1 year, after 2 years

    Number and percentage

  5. Inconclusive or non-malignant findings on low dose CT scans

    Time frame: Baseline, after 1 year, after 2 years

    Number and percentage

  6. FEV1

    Time frame: Baseline

    Measured in liters by a lung function test

  7. FVC

    Time frame: Baseline

    Measured in liters by a lung function test

  8. Treatment diagnose - cancer

    Time frame: 36 months (complete study period)

    number and percentage of treatments by action diagnosis related to cancer

  9. Hospitalization time

    Time frame: 36 months (complete study period)

    Hospitalization time related to lung cancer diagnosis measures in days

  10. Treatment diagnose - any other disease (found on low dose CT scans)

    Time frame: 36 months (complete study period)

    number and percentage of treatment diagnosis related to findings of other diseases (by action diagnosis)

  11. Referral to follow-up procedures

    Time frame: 36 months Entire study period

    Number of referrals

  12. Self reported health and quality of life assessed by the EQ-5D-5L questionnair

    Time frame: Baseline and after 2 years

    level of percieved problems are coded from level 1 to 5 in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression"

  13. Self-reported smoking status

    Time frame: Baseline, after 1 year, after 2 years

    Yes/no/former smoker

  14. All-cause-mortality

    Time frame: 36 months (the entire study period)

    Number of deaths in both groups (intervention/no intervention)

  15. Gender

    Time frame: Baseline

    Male/female

  16. Weight

    Time frame: Baseline

    Kilogram

  17. Height

    Time frame: Baseline

    Centimeters

  18. Smoking history

    Time frame: baseline

    according to the PLCOm2012 risk model

  19. Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases

    Time frame: 36 months

    hours

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: PLUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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