Dutch Belgian randomised lung cancer screening trial (NELSON).

Today, only 20% of lung cancers are at a resectable stage (stage I/II). 5-year survival is therefore low (15%). Computed Tomography (CT) screening detects more lung cancers than chest X-ray. It is unknown if this will translate into a lung cancer mortality reduction. The purpose of the NELSON trial is -to establish in a randomised controlled trial if screening for lung cancer by multi-slice low-dose CT in high risk subjects will lead to a 25% decrease in lung cancer mortality -to estimate the impact of lung cancer screening on health related quality of life and smoking cessation, and -to estimate cost-effectiveness and help policy making. Subjects with a high risk for lung cancer were first identified from the general population by sending a health questionnaire to approximately 500,000 men and women aged 50-74 in seven Dutch public health districts and 17 municipalities in Belgium. Eligible responders (n=30,134) were invited to participate. These were current smokers (55%) and former smokers (45%) who (had) smoked at least 16 cigarettes a day for at least 26 years or at least 11 cigarettes a day for at least 31 years. This was estimated to be the most optimal trial population. After giving informed consent (51.5%), 15,523 participants were randomised so far (1:1) to receive screening in year 1, 2 and 4 or usual care. The remaining 4,050 subjects needed to reach 80% power have been recruited in Denmark, and the Danish trial results will be uploaded at regular intervals to our database. CT screenings started in April 2004, performed with 16-detector multi-slice Spiral CT scanners and Siemens Lungcare® workstations and software for volumetric analyses. Both responders and trial participants appeared to be representative of the Dutch population of (heavy) current or former smokers. All baseline screenings and half of the second round screenings have at present been performed. At baseline screening, nodules have been categorised according to size and structure, at annual repeat screening according to the presence or absence of growth and according to volume doubling time (or being a new nodule). In the years 2007-2010 second and fourth year screens will be finalised. Lung cancer and all cause mortality in both study arms will be traced by linking our database to Statistics Netherlands and CBG. Causes of death of all lung cancer patients will be assessed by a review committee. Lung cancer cases, stages and tumor characteristics in both arms will be assessed by linkage to the regional cancer registries to estimate lead time and sensitivity. In a large subcohort quality of life around screening, assessment and diagnosis will be assessed. At 1 and 3-year follow up, smoking patterns and attitudes will be assessed. All smokers receive general or tailored smoking cessation advice. Effects and costs will be estimated with a MISCAN model for lung cancer screening.

1. To establish in a randomised controlled trial if screening for lung cancer by multi-slice low-dose CT in high risk subjects will lead to a 25% decrease in lung cancer mortality;

2. To estimate the impact of lung cancer screening on health related quality of life and smoking cessation;

3. To estimate cost-effectiveness and help policy making.

1. Screen arm:

a. 16-detector multi-slice computed tomography of the chest in year 1, 2 and 4 of the study;

b. Pulmonory function test;

c. Blood sampling;

d. Questionnaires;

e. Smoking cessation advice for current smokers.




2. Control arm:

smoking cessation advice for current smokers;




3. A sample of controls:

a. Pulmonory function test;

b. Blood sampling;

c. Questionnaires.