Screening by low-dose CT scan
RadiationScreening for lung cancer by low-dose CT scan
NCT Number: NCT06537804
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.
This study is active but is not currently recruiting participants.
60 year–74 year
All sexes
Interventional
Not applicable
Odense University Hospital, Odense, Region Syddanmark, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Screening for lung cancer by low-dose CT scan
Time frame: Up to 36 months
ratio
Time frame: Up to 36 months
Registry data
Time frame: 36 months (complete study period)
Number and percentage of citizens completing the screening trial
Time frame: 36 months (complete study period)
Number and percentage of citizens included that dropout during the study period
Time frame: Baseline, after 1 year, after 2 years
Number and percentage
Time frame: Baseline, after 1 year, after 2 years
Number and percentage
Time frame: Baseline
Measured in liters by a lung function test
Time frame: Baseline
Measured in liters by a lung function test
Time frame: 36 months (complete study period)
number and percentage of treatments by action diagnosis related to cancer
Time frame: 36 months (complete study period)
Hospitalization time related to lung cancer diagnosis measures in days
Time frame: 36 months (complete study period)
number and percentage of treatment diagnosis related to findings of other diseases (by action diagnosis)
Time frame: 36 months Entire study period
Number of referrals
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"
Time frame: Baseline, after 1 year, after 2 years
Yes/no/former smoker
Time frame: 36 months (the entire study period)
Number of deaths in both groups (intervention/no intervention)
Time frame: Baseline
Male/female
Time frame: Baseline
Kilogram
Time frame: Baseline
Centimeters
Time frame: baseline
according to the PLCOm2012 risk model
Time frame: 36 months
hours
Odense University Hospital
Other
Acronym: PLUS
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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