The Danish randomized lung cancer CT screening trial--overall design and results of the prevalence round.
BACKGROUND
Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway.


METHODS
In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either screening with annual low dose CT scans for 5 years or no screening. A history of cigarette smoking of at least 20 pack years was required. All participants have annual lung function tests, and questionnaires regarding health status, psychosocial consequences of screening, smoking habits, and smoking cessation. Baseline CT scans were performed in 2052 participants. Pulmonary nodules were classified according to size and morphology: (1) Nodules smaller than 5 mm and calcified (benign) nodules were tabulated, (2) Noncalcified nodules between 5 and 15 mm were rescanned after 3 months. If the nodule increased in size or was larger than 15 mm the participant was referred for diagnostic workup.


RESULTS
At baseline 179 persons showed noncalcified nodules larger than 5 mm, and most were rescanned after 3 months: The rate of false-positive diagnoses was 7.9%, and 17 individuals (0.8%) turned out to have lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection.


CONCLUSIONS
Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false-positive screen results compared with previous studies on lung cancer screening.
Pedersen
Jesper H
JH
Department of Thoracic Surgery RT, Rigshospitalet, University of Copenhagen, Denmark. jesper.holst.pedersen@rh.regionh.dk
Ashraf
Haseem
H
Dirksen
Asger
A
Bach
Karen
K
Hansen
Hanne
H
Toennesen
Phillip
P
Thorsen
Hanne
H
Brodersen
John
J
Skov
Birgit Guldhammer
BG
Døssing
Martin
M
Mortensen
Jann
J
Richter
Klaus
K
Clementsen
Paul
P
Seersholm
Niels
N
D000230:Adenocarcinoma / Q000000981:diagnostic imaging* / Q000473:pathology; D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000000981:diagnostic imaging* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging* / Q000473:pathology; D003718:Denmark / Q000453:epidemiology; D055088:Early Detection of Cancer; D015340:Epidemiologic Research Design; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D009367:Neoplasm Staging; D015995:Prevalence; D011379:Prognosis; D012680:Sensitivity and Specificity; D012907:Smoking / Q000453:epidemiology; D014057:Tomography, X-Ray Computed