Condition category
Cancer
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
04/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

http://www.nelsonproject.nl

Contact information

Type

Scientific

Primary contact

Prof HJ de Koning

ORCID ID

Contact details

Erasmus Medical Centre
Department of Public Health
PO Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 7038471
h.dekoning@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR636

Study information

Scientific title

Dutch Belgian randomised lung cancer screening trial (NELSON)

Acronym

NELSON

Study hypothesis

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

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.

Study design

Multicentre randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Lung cancer mortality (reduction)

Secondary outcome measures

1. Cost-effectiveness
2. Quality of life

Overall trial start date

16/08/2003

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

15600

Participant 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

Recruitment start date

16/08/2003

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

PO Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Koningin Wilhelmina Fonds (KWF) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stichting Tegen Kanker

Alternative name(s)

Belgian Foundation Against Cancer, Fondation Contre le Cancer

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Belgium

Funder name

Erasmus Trust Fund (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

G. Ph. Verhagen Foundation (G. Ph. Verhagen Stichting) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Siemens

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Funder name

Stichting Central Fund Reserves of Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Rotterdam Oncology Thoracic Steering Committee (ROTS) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17709835
2. 2009 patient participation results in: http://www.ncbi.nlm.nih.gov/pubmed/19282345
3. 2009 results on management of lung nodules in: http://www.ncbi.nlm.nih.gov/pubmed/19955524
4. 2010 2-year follow up data in: http://www.ncbi.nlm.nih.gov/pubmed/20627916
5. 2011 results on health-related quality of life in: http://www.ncbi.nlm.nih.gov/pubmed/21148229
6. 2012 generalisability of results in: http://www.ncbi.nlm.nih.gov/pubmed/22459203
7. 2012 complications results in: http://www.ncbi.nlm.nih.gov/pubmed/22491665
8. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22302298
9. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22323577
10. 2013 follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/23688060
11. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23845716
12. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282285
13. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282284
14. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25182625
15. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25287262
16. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25413965
17. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25664626
18. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25962863
19. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27283862
20. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27364640

Publication citations

  1. Results

    Gietema HA, Schilham AM, van Ginneken B, van Klaveren RJ, Lammers JW, Prokop M, Monitoring of smoking-induced emphysema with CT in a lung cancer screening setting: detection of real increase in extent of emphysema., Radiology, 2007, 244, 3, 890-897, doi: 10.1148/radiol.2443061330.

  2. Results on patient participation results

    van den Bergh KA, Essink-Bot ML, van Klaveren RJ, de Koning HJ, Informed participation in a randomised controlled trial of computed tomography screening for lung cancer., Eur. Respir. J., 2009, 34, 3, 711-720, doi: 10.1183/09031936.00098908.

  3. Results on management of lung nodules

    van Klaveren RJ, Oudkerk M, Prokop M, Scholten ET, Nackaerts K, Vernhout R, van Iersel CA, van den Bergh KA, van 't Westeinde S, van der Aalst C, Thunnissen E, Xu DM, Wang Y, Zhao Y, Gietema HA, de Hoop BJ, Groen HJ, de Bock GH, van Ooijen P, Weenink C, Verschakelen J, Lammers JW, Timens W, Willebrand D, Vink A, Mali W, de Koning HJ, Management of lung nodules detected by volume CT scanning., N. Engl. J. Med., 2009, 361, 23, 2221-2229, doi: 10.1056/NEJMoa0906085.

  4. Generalisability of results

    van der Aalst CM, van Iersel CA, van Klaveren RJ, Frenken FJ, Fracheboud J, Otto SJ, de Jong PA, Oudkerk M, de Koning HJ, Generalisability of the results of the Dutch-Belgian randomised controlled lung cancer CT screening trial (NELSON): does self-selection play a role?, Lung Cancer, 2012, 77, 1, 51-57, doi: 10.1016/j.lungcan.2012.02.021.

  5. Complications results

    Van't Westeinde SC, Horeweg N, De Leyn P, Groen HJ, Lammers JW, Weenink C, Nackaerts K, van Klaveren RJ, Complications following lung surgery in the Dutch-Belgian randomized lung cancer screening trial., Eur J Cardiothorac Surg, 2012, 42, 3, 420-429, doi: 10.1093/ejcts/ezs081.

  6. Results

    van 't Westeinde SC, Horeweg N, Vernhout RM, Groen HJ, Lammers JW, Weenink C, Nackaerts K, Oudkerk M, Mali W, Thunnissen FB, de Koning HJ, van Klaveren RJ, The role of conventional bronchoscopy in the workup of suspicious CT scan screen-detected pulmonary nodules., Chest, 2012, 142, 2, 377-384, doi: 10.1378/chest.11-2030.

  7. Results

    Mohamed Hoesein FA, van Rikxoort E, van Ginneken B, de Jong PA, Prokop M, Lammers JW, Zanen P, Computed tomography-quantified emphysema distribution is associated with lung function decline., Eur. Respir. J., 2012, 40, 4, 844-850, doi: 10.1183/09031936.00186311.

  8. Results

    Horeweg N, van der Aalst CM, Vliegenthart R, Zhao Y, Xie X, Scholten ET, Mali W, Thunnissen E, Weenink C, Groen HJ, Lammers JW, Nackaerts K, van Rosmalen J, Oudkerk M, de Koning HJ, Volumetric computed tomography screening for lung cancer: three rounds of the NELSON trial., Eur. Respir. J., 2013, 42, 6, 1659-1667, doi: 10.1183/09031936.00197712.

  9. Results

    Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, Ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M, Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening., Lancet Oncol., 2014, doi: 10.1016/S1470-2045(14)70389-4.

  10. van der Aalst CM, van den Bergh KA, Willemsen MC, de Koning HJ, van Klaveren RJ, Lung cancer screening and smoking abstinence: 2 year follow-up data from the Dutch-Belgian randomised controlled lung cancer screening trial., Thorax, 2010, 65, 7, 600-605, doi: 10.1136/thx.2009.133751.

  11. van den Bergh KA, Essink-Bot ML, Borsboom GJ, Scholten ET, van Klaveren RJ, de Koning HJ, Long-term effects of lung cancer computed tomography screening on health-related quality of life: the NELSON trial., Eur. Respir. J., 2011, 38, 1, 154-161, doi: 10.1183/09031936.00123410.

  12. Mohamed Hoesein FA, Zanen P, de Jong PA, van Ginneken B, Boezen HM, Groen HJ, Oudkerk M, de Koning HJ, Postma DS, Lammers JW, Rate of progression of CT-quantified emphysema in male current and ex-smokers: a follow-up study., Respir. Res., 2013, 14, 55, doi: 10.1186/1465-9921-14-55.

  13. Results

    Horeweg N, Scholten ET, de Jong PA, van der Aalst CM, Weenink C, Lammers JW, Nackaerts K, Vliegenthart R, ten Haaf K, Yousaf-Khan UA, Heuvelmans MA, Thunnissen E, Oudkerk M, Mali W, de Koning HJ, Detection of lung cancer through low-dose CT screening (NELSON): a prespecified analysis of screening test performance and interval cancers, Lancet Oncol, 2014 , 15, 12, 1342-1350, doi: 10.1016/S1470-2045(14)70387-0.

  14. Results

    Takx RA, Vliegenthart R, Mohamed Hoesein FA, Išgum I, de Koning HJ, Mali WP, van der Aalst CM, Zanen P, Lammers JW, Groen HJ, van Rikxoort EM, Schmidt M, van Ginneken B, Oudkerk M, Leiner T, de Jong PA, Pulmonary function and CT biomarkers as risk factors for cardiovascular events in male lung cancer screening participants: the NELSON study, Eur Radiol, 2015, 25, 1, 65-71, doi: 10.1007/s00330-014-3384-6.

  15. Results

    Scholten ET, Jacobs C, van Ginneken B, van Riel S, Vliegenthart R, Oudkerk M, de Koning HJ, Horeweg N, Prokop M, Gietema HA, Mali WP, de Jong PA, Detection and quantification of the solid component in pulmonary subsolid nodules by semiautomatic segmentation, Eur Radiol, 2015, 25, 2, 488-496, doi: 10.1007/s00330-014-3427-z.

  16. Results

    Scholten ET, de Jong PA, Jacobs C, van Ginneken B, van Riel S, Willemink MJ, Vliegenthart R, Oudkerk M, de Koning HJ, Horeweg N, Prokop M, Mali WP, Gietema HA, Interscan variation of semi-automated volumetry of subsolid pulmonary nodules, Eur Radiol, 2015 , 25, 4, 1040-1047, doi: 10.1007/s00330-014-3478-1.

  17. Results

    Yousaf-Khan U1, Horeweg N, van der Aalst C, Ten Haaf K, Oudkerk M, de Koning H, Baseline Characteristics and Mortality Outcomes of Control Group Participants and Eligible Non-Responders in the NELSON Lung Cancer Screening Study, J Thorac Oncol., 2015, 10, 5, 747-753, doi: 10.1097/JTO.0000000000000488.

  18. Results

    Willemink MJ, Takx RA, Išgum I, de Koning HJ, Oudkerk M, Mali WP, Budde RP, Leiner T, Vliegenthart R, de Jong PA, Prognostic value of heart valve calcifications for cardiovascular events in a lung cancer screening population, Int J Cardiovasc Imaging, 2015 , 31, 6, 1243-1249, doi: 10.1007/s10554-015-0664-4.

  19. Results

    Walter JE, Heuvelmans MA, de Jong PA, Vliegenthart R, van Ooijen PM, Peters RB, Ten Haaf K, Yousaf-Khan U5, van der Aalst CM, de Bock GH, Mali W, Groen HJ, de Koning HJ, Oudkerk M, Occurrence and lung cancer probability of new solid nodules at incidence screening with low-dose CT: analysis of data from the randomised, controlled NELSON trial, Lancet Oncol, 2016, S1470-2045(16)30069-9, doi: 10.1016/S1470-2045(16)30069-9.

  20. Results

    Yousaf-Khan U, van der Aalst C, de Jong PA, Heuvelmans M, Scholten E, Lammers JW, van Ooijen P, Nackaerts K, Weenink C, Groen H, Vliegenthart R, Ten Haaf K, Oudkerk M, de Koning H, Final screening round of the NELSON lung cancer screening trial: the effect of a 2.5-year screening interval, Thorax, 2016, thoraxjnl-2016-208655, doi: 10.1136/thoraxjnl-2016-208655.

Additional files

Editorial Notes

04/07/2016: Publication reference added. 13/06/2016: Publication reference added. 14/04/2016: Publication reference added. 22/03/2016: Publication reference added.