Dutch Belgian randomised lung cancer screening trial (NELSON)

ISRCTN ISRCTN63545820
DOI https://doi.org/10.1186/ISRCTN63545820
Secondary identifying numbers NTR636
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

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

Study website

Contact information

Prof HJ de Koning
Scientific

Erasmus Medical Centre
Department of Public Health
PO Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 7038471
Email h.dekoning@erasmusmc.nl

Study information

Study designMulticentre randomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDutch Belgian randomised lung cancer screening trial (NELSON)
Study acronymNELSON
Study hypothesis1. 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.
ConditionLung cancer
Intervention1. 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 typeOther
Primary outcome measureLung cancer mortality (reduction)
Secondary outcome measures1. Cost-effectiveness
2. Quality of life
Overall study start date16/08/2003
Overall study end date31/12/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants15600
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date16/08/2003
Recruitment end date31/12/2015

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

PO Box 2040
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

Vlaamse League Against Cancer (Vlaamse Liga tegen Kanker) (Netherlands)

No information available

Koningin Wilhelmina Fonds (KWF) (Netherlands)

No information available

Stichting Tegen Kanker
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Belgium Foundation Against Cancer, Fondation Contre le Cancer
Location
Belgium
Erasmus Trust Fund (Netherlands)

No information available

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands
G. Ph. Verhagen Foundation (G. Ph. Verhagen Stichting) (Netherlands)

No information available

Siemens
Private sector organisation / For-profit companies (industry)
Location
Germany
Stichting Central Fund Reserves of Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ]) (Netherlands)

No information available

Rotterdam Oncology Thoracic Steering Committee (ROTS) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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
Other publications 2-year follow up data 01/07/2010 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
Other publications 01/08/2018 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

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.