This trial is active, not recruiting.

Condition lung cancer
Treatment annual ct screening
Sponsor Danish Lung Cancer Group
Collaborator Ministry of the Interior and Health, Denmark
Start date October 2004
End date January 2010
Trial size 4104 participants
Trial identifier NCT00496977, KA-02045


The trial is a randomised trial comparing annual CT screening for lung cancer with no screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 % (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological effects of screening including the effects of false positive diagnoses, and 3) to evaluate possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of Interior and Health.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose screening

Primary Outcomes

Lung cancer mortality
time frame: 10 years

Secondary Outcomes

lung cancer incidense and stagedistribution
time frame: 5 years

Eligibility Criteria

Male or female participants from 50 years up to 70 years old.

Inclusion Criteria: - Smoking exposure > 20 pack years - Quit smoking < 10 years - Fit to undergo treatment - Pulmonary function test > 30 % of expected (FEV1) Exclusion Criteria: - Bodyweight > 130 Kg - Formely treated for lungcancer, breastcancer, melanoma or hypernephroma. - Serious co-morbidity with life expectancy below 10 years. - Treated for other malignant diseases within the last 5 years. - Treatment for pulmonary tuberculosis within the last 2 years.

Additional Information

Official title Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.
Principal investigator Jesper H Pedersen, MD, Dr.Sci
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2007.
Information provided to ClinicalTrials.gov by Danish Lung Cancer Group.