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22 May 2013
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| [ Print-friendly version ] |
| 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 | Not provided at time of registration |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| 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 |
| Contact name | Mr R J van Klaveren |
| Address |
Erasmus Medical Centre
Department of Pulmonology P.O. Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CA |
| Country | Netherlands |
| Tel | +31 (0)10 4631437 |
| Fax | +31 (0)10 4391044 |
| r.j.vanklaveren@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 | 21/03/2013 |
| Date ISRCTN assigned | 07/06/2006 |
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