Dutch Belgian randomised lung cancer screening trial (NELSON)
| ISRCTN | ISRCTN63545820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63545820 |
| Protocol serial number | NTR636 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funders | Vlaamse League Against Cancer (Vlaamse Liga tegen Kanker) (Netherlands), Koningin Wilhelmina Fonds (KWF) (Netherlands), Stichting Tegen Kanker, Erasmus Trust Fund (Netherlands), Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), G. Ph. Verhagen Foundation (G. Ph. Verhagen Stichting) (Netherlands), Siemens, Stichting Central Fund Reserves of Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ]) (Netherlands), Rotterdam Oncology Thoracic Steering Committee (ROTS) (Netherlands) |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 25/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lung cancer is the leading cause of cancer death worldwide and accounts for approximately 28% of all cancer deaths worldwide. Despite advances in medical diagnostics and treatment, the outlook for lung cancer has not improved considerably during the last few decades. New developments in CT scanning have led to a renewed interest in lung cancer screening. Although studies have shown that screening reduces the number of lung cancer deaths, the cost-effectiveness, the best screening policy, and the balance between harms and benefits are still unknown. The aims of this study are: to investigate whether screening in a high-risk population leads to a reduction in lung cancer deaths of at least 25%; to estimate the impact of lung cancer screening on health-related quality of life and smoking cessation; and to estimate the cost-effectiveness of lung cancer screening for subgroups.
Who can participate?
People aged between 50 and 75 who were current smokers or former smokers who had quit smoking less than 10 years ago.
What does the study involve?
Participants are randomly allocated to either the screening or the control group. Screening group participants receive CT screening for lung cancer over several years, whereas participants in the control group receive no screening (usual care).
What are the possible benefits and risks of participating?
It is a feature of screening programmes that relatively few of the people who are invited for screening benefit from it, while a relatively large number of them will be exposed to minor unfavourable effects. In considering whether screening is justified, it is important to ensure that the favourable effects of screening (fewer deaths) should reasonably balance out the harms caused by screening (overdiagnosis, overtreatment, false-positive screening result, anxiety, discomfort etc). This will be investigated by this study.
Where is the study run from?
Department of Public Health, Erasmus MC, Rotterdam, The Netherlands. Participating centres: University Medical Centre Groningen, University Medical Centre Utrecht, Kennemer Gasthuis Haarlem (the Netherlands), and University Hospital Leuven (Belgium).
When is the study starting and how long is it expected to run for?
August 2003 to December 2015
Who is funding the study?
The Netherlands Organisation of Health Research and Development (ZonMw), the Dutch Cancer Society (KWF), and the Health Insurance Innovation Foundation (Innovatiefonds Zorgverzekeraars), Siemens Germany, Roche Diagnostics, G. Ph. Verhagen Stichting, Rotterdam Oncologic Thoracic Study (ROTS) group, Erasmus Trust Fund, Stichting tegen Kanker, Vlaamse Liga tegen Kanker, and LOGO Leuven.
Who is the main contact?
Prof. Dr H.J. de Koning
h.dekoning@erasmusmc.nl
Contact information
Scientific
Erasmus Medical Centre
Department of Public Health
PO Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 7038471 |
|---|---|
| h.dekoning@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel-group trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Dutch Belgian randomised lung cancer screening trial (NELSON) |
| Study acronym | NELSON |
| Study objectives | 1. To establish in a randomised controlled trial if screening for lung cancer by multi-slice low-dose computed tomography (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 |
| Ethics approval(s) | The Minister of Health approved the NELSON trial after a positive advice of the Dutch Health Council (22/11/2000), because of the Population Screening Act. Furthermore, the Medical Ethical committees of the participating centers (University Medical Centre Groningen, University Medical Centre Utrecht, Kennemer Gasthuis Haarlem [the Netherlands], and University Hospital Leuven [Belgium]) also gave their approval. |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | 1. Screen arm: 1.1. 16-detector multi-slice computed tomography of the chest in year one, two and four of the study 1.2. Pulmonary function test 1.3. Blood sampling 1.4. Questionnaires 1.5. Smoking cessation advice for current smokers 2. Control arm: Smoking cessation advice for current smokers. 3. A sample of controls: 3.1. Pulmonary function test 3.2. Blood sampling 3.3. Questionnaires |
| Intervention type | Other |
| Primary outcome measure(s) |
Lung cancer mortality (reduction) |
| Key secondary outcome measure(s) |
1. Cost-effectiveness |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 15600 |
| Key inclusion criteria | 1. Born between 1928 and 1956 2. Smoked: 2.1. More than 15 cigarettes per day for more than 25 years, or 2.2. More than 10 cigarettes per day for more than 30 years 3. Current or former smokers who quit smoking less than or equal to 10 years ago |
| Key exclusion criteria | 1. Moderate or bad self-reported health who were unable to climb two flights of stairs 2. Body weight greater than or equal to 140 kg 3. Current or past renal cancer, melanoma or breast cancer 4. Lung cancer, diagnosed less than five years ago or greater than or equal to five years but still under treatment 5. Had a chest CT examination less than one year before they filled in the first NELSON questionnaire |
| Date of first enrolment | 16/08/2003 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | Yes | No | |
| Results article | patient participation results | 01/09/2009 | Yes | No | |
| Results article | results on management of lung nodules | 03/12/2009 | Yes | No | |
| Results article | results on health-related quality of life | 01/07/2011 | Yes | No | |
| Results article | generalisability of results | 01/07/2012 | Yes | No | |
| Results article | results | 01/08/2012 | Yes | No | |
| Results article | complications results | 01/09/2012 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No | |
| Results article | follow-up results | 20/05/2013 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | results | 01/05/2015 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 15/07/2016 | Yes | No | |
| Results article | results | 01/01/2017 | Yes | No | |
| Results article | results | 01/08/2018 | Yes | No | |
| Results article | results | 01/03/2019 | 16/05/2019 | Yes | No |
| Results article | results | 01/09/2018 | 25/09/2019 | Yes | No |
| Other publications | 2-year follow up data | 01/07/2010 | Yes | No | |
| Other publications | 01/08/2018 | Yes | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/09/2019: Publication reference added.
16/05/2019: Publication reference added.
07/02/2019: Publication references added.
23/02/2018: Publication reference added.
04/07/2016: Publication reference added.
13/06/2016: Publication reference added.
14/04/2016: Publication reference added.
22/03/2016: Publication reference added.
