Project Lung Cancer Screening in Southern Denmark

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer
• Interventions: Radiation: Screening by low-dose CT scan

• Registration Number: NCT06537804
• Lead Sponsor: Odense University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study Start: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Screening by low-dose CT scan	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).

Primary Outcome Measures

Name	Time	Method
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold	Up to 36 months	ratio

Secondary Outcome Measures

Name	Time	Method
Inconclusive or non-malignant findings on low dose CT scans	Baseline, after 1 year, after 2 years	Number and percentage
FVC	Baseline	Measured in liters by a lung function test
Hospitalization time	36 months (complete study period)	Hospitalization time related to lung cancer diagnosis measures in days
Self-reported smoking status	Baseline, after 1 year, after 2 years	Yes/no/former smoker
Weight	Baseline	Kilogram
All-cause-mortality	36 months (the entire study period)	Number of deaths in both groups (intervention/no intervention)
Characteristics of citizens from the cohort based on registry data	Up to 36 months	Registry data
Participation rate	36 months (complete study period)	Number and percentage of citizens completing the screening trial
Dropouts	36 months (complete study period)	Number and percentage of citizens included that dropout during the study period
Lung cancer found on low dose CT-scans	Baseline, after 1 year, after 2 years	Number and percentage
FEV1	Baseline	Measured in liters by a lung function test
Treatment diagnose - any other disease (found on low dose CT scans)	36 months (complete study period)	number and percentage of treatment diagnosis related to findings of other diseases (by action diagnosis)
Referral to follow-up procedures	36 months Entire study period	Number of referrals
Self reported health and quality of life assessed by the EQ-5D-5L questionnair	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"
Gender	Baseline	Male/female
Treatment diagnose - cancer	36 months (complete study period)	number and percentage of treatments by action diagnosis related to cancer
Height	Baseline	Centimeters
Smoking history	baseline	according to the PLCOm2012 risk model
Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases	36 months	hours