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Dutch Belgian randomised lung cancer screening trial (NELSON)
ISRCTN ISRCTN63545820
DOI 10.1186/ISRCTN63545820
ClinicalTrials.gov identifier
EudraCT number
Public title Dutch Belgian randomised lung cancer screening trial (NELSON)
Scientific title
Acronym NELSON
Serial number at source NTR636
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
Lay summary Lay summary under review 2
Ethics approval Added 16/09/2013: 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
Countries of recruitment Belgium, Netherlands
Disease/condition/study domain Lung cancer
Participants - 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
Participants - 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
Anticipated start date 16/08/2003
Anticipated end date 31/12/2015
Status of trial Ongoing
Patient information material
Target number of participants 15600
Interventions 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
Primary outcome measure(s) Lung cancer mortality (reduction)
Secondary outcome measure(s) 1. Cost-effectiveness
2. Quality of life
Sources of funding 1. Vlaamse League Against Cancer (Vlaamse Liga tegen Kanker) (Netherlands)
2. Koningin Wilhelmina Fonds (KWF) (Netherlands)
3. Foundation Against Cancer (Stichting tegen Kanker) (Netherlands)
4. Erasmus Trust Fund (Netherlands)
5. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
6. G. Ph. Verhagen Foundation (G. Ph. Verhagen Stichting) (Netherlands)
7. Siemens (Germany)
8. Stichting Central Fund Reserves of Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ]) (Netherlands)
9. Rotterdam Oncology Thoracic Steering Committee (ROTS) (Netherlands)
Trial website http://www.nelsonproject.nl
Publications 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
Contact name Prof  HJ  de Koning
  Address Erasmus Medical Centre
Department of Public Health
P.O. Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Tel +31 (0)10 7038471
  Fax +31 (0)10 7038475
  Email h.dekoning@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address P.O. Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Sponsor website: http://www.erasmusmc.nl/
Date applied 07/06/2006
Last edited 02/10/2013
Date ISRCTN assigned 07/06/2006
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