Condition category
Cancer
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
06/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review 2

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
P.O. 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

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 controlled trial

Trial setting

Hospitals

Trial type

Screening

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

Patient

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

P.O. 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

Foundation Against Cancer (Stichting tegen Kanker) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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)

ZonMw

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 (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 results on patient participation results 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

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.

Additional files

Editorial Notes