Lung CancerPLUSNCT06537804
Project Lung Cancer Screening in Southern Denmark
A study testing Screening by low-dose CT scan in people with Lung Cancer, run by Odense University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Screening by low-dose CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,332 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Odense University Hospital
Odense, Region Syddanmark, 5000
Department of Radiology, Svendborg Hospital
Svendborg, Region Syddanmark, 5700
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Screening by low-dose CT scan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening by low-dose CT scanRadiation
Screening for lung cancer by low-dose CT scan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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). Receives: Radiation: Screening by low-dose CT scan |
| Control | No intervention | Citizens from the cohort who are randomized to no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold
ratio
Measured: Up to 36 months
Secondary outcomes (19)
Characteristics of citizens from the cohort based on registry data
Registry data
Measured: Up to 36 months
Participation rate
Number and percentage of citizens completing the screening trial
Measured: 36 months (complete study period)
Dropouts
Number and percentage of citizens included that dropout during the study period
Measured: 36 months (complete study period)
Lung cancer found on low dose CT-scans
Number and percentage
Measured: Baseline, after 1 year, after 2 years
Inconclusive or non-malignant findings on low dose CT scans
Number and percentage
Measured: Baseline, after 1 year, after 2 years
FEV1
Measured in liters by a lung function test
Measured: Baseline
FVC
Measured in liters by a lung function test
Measured: Baseline
Treatment diagnose - cancer
number and percentage of treatments by action diagnosis related to cancer
Measured: 36 months (complete study period)
Hospitalization time
Hospitalization time related to lung cancer diagnosis measures in days
Measured: 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)
Measured: 36 months (complete study period)
Referral to follow-up procedures
Number of referrals
Measured: 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"
Measured: Baseline and after 2 years
Self-reported smoking status
Yes/no/former smoker
Measured: Baseline, after 1 year, after 2 years
All-cause-mortality
Number of deaths in both groups (intervention/no intervention)
Measured: 36 months (the entire study period)
Gender
Male/female
Measured: Baseline
Weight
Kilogram
Measured: Baseline
Height
Centimeters
Measured: Baseline
Smoking history
according to the PLCOm2012 risk model
Measured: baseline
Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases
hours
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start5 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Stenger, Consultant, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537804
- Sponsor's protocol ID
- S-20240033
- Acronym
- PLUS
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Lung Cancer Screening in Southern Denmark
- ClinicalTrials.gov ID
- NCT06537804
- Acronym / sponsor ID
- PLUS / S-20240033
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,332 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Radiation: Screening by low-dose CT scanLow-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). |
| Control | No intervention | –Citizens from the cohort who are randomized to no intervention. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening by low-dose CT scanScreening for lung cancer by low-dose CT scan | Radiation | Intervention |
Primary outcome
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold
Time frame: Up to 36 months
ratio
19 secondary outcomes
Characteristics of citizens from the cohort based on registry data
Time frame: Up to 36 months
Participation rate
Time frame: 36 months (complete study period)
Dropouts
Time frame: 36 months (complete study period)
Lung cancer found on low dose CT-scans
Time frame: Baseline, after 1 year, after 2 years
Inconclusive or non-malignant findings on low dose CT scans
Time frame: Baseline, after 1 year, after 2 years
FEV1
Time frame: Baseline
FVC
Time frame: Baseline
Treatment diagnose - cancer
Time frame: 36 months (complete study period)
Hospitalization time
Time frame: 36 months (complete study period)
Treatment diagnose - any other disease (found on low dose CT scans)
Time frame: 36 months (complete study period)
Referral to follow-up procedures
Time frame: 36 months Entire study period
Self reported health and quality of life assessed by the EQ-5D-5L questionnair
Time frame: Baseline and after 2 years
Self-reported smoking status
Time frame: Baseline, after 1 year, after 2 years
All-cause-mortality
Time frame: 36 months (the entire study period)
Gender
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Smoking history
Time frame: baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stenger, Consultant study director
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening by low-dose CT scan in people with Lung Cancer, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.