Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.
The trial is a parallel randomized controlled trial comparing either a yearly low dose CT
scan or no screening. It is scheduled to enroll 4000 smokers and former smokers, and the
study is scheduled to last 5 years, i.e. an initial (prevalence) screening is followed by 4
annual (incidence) screenings.
In addition the following investigations are done: A prospective, longitudinal
questionnaire assessment of enrolled participants who have received a false positive
diagnosis. The questionnaire will focus on the consequences of receiving a false positive
diagnosis. Answers from enrolled subjects who have received a false positive diagnosis will
be compared to their own “baseline” responses, and responses from subjects who have received
a negative result of their own low-dose CT scans All participants will annually be
questioned regarding smoking habits, their motivation for cessation of smoking and will be
advised to refrain from smoking to assess the effect of participation in a screening
protocol for lung cancer on cessation of smoking.
Socioeconomic consequences of screening for lung cancer will be assessed by longitudinal
registration of costs and benefits (e.g. morbidity, hospitalization, GP consultations etc.
Assess the value of PET scanning when screening for lung cancer.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Screening
Lung cancer mortality
Jesper H Pedersen, MD, Dr.Sci
Gentofte University Hospital, Hellerup, Denmark
Denmark: Danish Dataprotection Agency