NCT00496977

Brief Summary

The trial is a randomised trial comparing annual CT screening for lung cancer with no screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 % (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological effects of screening including the effects of false positive diagnoses, and 3) to evaluate possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of Interior and Health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,104

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 6, 2007

Status Verified

June 1, 2007

First QC Date

July 5, 2007

Last Update Submit

July 5, 2007

Conditions

Lung Cancer

Keywords

lung cancerCT scanscreening

Outcome Measures

Primary Outcomes (1)

  • Lung cancer mortality

    10 years

Secondary Outcomes (1)

  • lung cancer incidense and stagedistribution

    5 years

Interventions

annual CT screeningPROCEDURE

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking exposure \> 20 pack years
  • Quit smoking \< 10 years
  • Fit to undergo treatment
  • Pulmonary function test \> 30 % of expected (FEV1)

You may not qualify if:

  • Bodyweight \> 130 Kg
  • Formely treated for lungcancer, breastcancer, melanoma or hypernephroma.
  • Serious co-morbidity with life expectancy below 10 years.
  • Treated for other malignant diseases within the last 5 years.
  • Treatment for pulmonary tuberculosis within the last 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lung Screening Clinic, Gentofte University Hospital

Hellerup, DK-2900, Denmark

Location

Related Publications (12)

  • Venkadesh KV, Aleef TA, Scholten ET, Saghir Z, Silva M, Sverzellati N, Pastorino U, van Ginneken B, Prokop M, Jacobs C. Prior CT Improves Deep Learning for Malignancy Risk Estimation of Screening-detected Pulmonary Nodules. Radiology. 2023 Aug;308(2):e223308. doi: 10.1148/radiol.223308.

    PMID: 37526548DERIVED

  • Rasmussen JF, Siersma V, Malmqvist J, Brodersen J. Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study. BMJ Open. 2020 Jun 4;10(6):e034682. doi: 10.1136/bmjopen-2019-034682.

    PMID: 32503869DERIVED

  • Malmqvist J, Siersma V, Thorsen H, Heleno B, Rasmussen JF, Brodersen J. Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study. BMJ Open. 2020 Feb 20;10(2):e030871. doi: 10.1136/bmjopen-2019-030871.

    PMID: 32086352DERIVED

  • Jensen MD, Siersma V, Rasmussen JF, Brodersen J. Direct and indirect healthcare costs of lung cancer CT screening in Denmark: a registry study. BMJ Open. 2020 Jan 21;10(1):e031768. doi: 10.1136/bmjopen-2019-031768.

    PMID: 31969362DERIVED

  • Wille MM, Dirksen A, Ashraf H, Saghir Z, Bach KS, Brodersen J, Clementsen PF, Hansen H, Larsen KR, Mortensen J, Rasmussen JF, Seersholm N, Skov BG, Thomsen LH, Tonnesen P, Pedersen JH. Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling. Am J Respir Crit Care Med. 2016 Mar 1;193(5):542-51. doi: 10.1164/rccm.201505-1040OC.

    PMID: 26485620DERIVED

  • Winkler Wille MM, van Riel SJ, Saghir Z, Dirksen A, Pedersen JH, Jacobs C, Thomsen LH, Scholten ET, Skovgaard LT, van Ginneken B. Predictive Accuracy of the PanCan Lung Cancer Risk Prediction Model -External Validation based on CT from the Danish Lung Cancer Screening Trial. Eur Radiol. 2015 Oct;25(10):3093-9. doi: 10.1007/s00330-015-3689-0. Epub 2015 Mar 13.

    PMID: 25764091DERIVED

  • Rasmussen JF, Siersma V, Pedersen JH, Brodersen J. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST). Lung Cancer. 2015 Jan;87(1):65-72. doi: 10.1016/j.lungcan.2014.11.003. Epub 2014 Nov 20.

    PMID: 25433982DERIVED

  • Ashraf H, Saghir Z, Dirksen A, Pedersen JH, Thomsen LH, Dossing M, Tonnesen P. Smoking habits in the randomised Danish Lung Cancer Screening Trial with low-dose CT: final results after a 5-year screening programme. Thorax. 2014 Jun;69(6):574-9. doi: 10.1136/thoraxjnl-2013-203849. Epub 2014 Jan 17.

    PMID: 24443174DERIVED

  • Thomsen LH, Dirksen A, Shaker SB, Skovgaard LT, Dahlback M, Pedersen JH. Analysis of FEV1 decline in relatively healthy heavy smokers: implications of expressing changes in FEV1 in relative terms. COPD. 2014 Feb;11(1):96-104. doi: 10.3109/15412555.2013.830096. Epub 2013 Oct 10.

    PMID: 24111638DERIVED

  • Rasmussen T, Frestad D, Kober L, Pedersen JH, Thomsen LH, Dirksen A, Kofoed KF. Development and progression of coronary artery calcification in long-term smokers: adverse effects of continued smoking. J Am Coll Cardiol. 2013 Jul 16;62(3):255-257. doi: 10.1016/j.jacc.2013.04.013. Epub 2013 Apr 30. No abstract available.

    PMID: 23643591DERIVED

  • Kaerlev L, Iachina M, Pedersen JH, Green A, Norgard BM. CT-Screening for lung cancer does not increase the use of anxiolytic or antidepressant medication. BMC Cancer. 2012 May 23;12:188. doi: 10.1186/1471-2407-12-188.

    PMID: 22621716DERIVED

  • Saghir Z, Ashraf H, Dirksen A, Brodersen J, Pedersen JH. Contamination during 4 years of annual CT screening in the Danish Lung Cancer Screening Trial (DLCST). Lung Cancer. 2011 Mar;71(3):323-7. doi: 10.1016/j.lungcan.2010.06.006.

    PMID: 20619924DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jesper H Pedersen, MD, Dr.Sci

    Gentofte University Hospital, Hellerup, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

October 1, 2004

Study Completion

January 1, 2010

Last Updated

July 6, 2007

Record last verified: 2007-06

Locations

DK(1)