Danish Lung Cancer Screening Trial (DLCST) (DLCST)

• ClinicalTrials.gov Identifier: NCT00496977
• Recruitment Status: Unknown
• First Posted: July 6, 2007
• Last Update Posted: July 6, 2007
• Sponsor: Danish Lung Cancer Group
• Collaborator: Ministry of the Interior and Health, Denmark
• Information provided by: Danish Lung Cancer Group

Tracking Information

• First Submitted Date: July 5, 2007
• First Posted Date: July 6, 2007
• Last Update Posted Date: July 6, 2007
• Study Start Date: October 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: July 5, 2007): Lung cancer mortality [ Time Frame: 10 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: July 5, 2007): lung cancer incidense and stagedistribution [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Danish Lung Cancer Screening Trial (DLCST)
• Official Title: Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.
• 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.

Detailed Description

The trial is a parallel randomized controlled trial comparing either a yearly low dose CT scan or no screening. It is scheduled to enroll 4000 smokers and former smokers, and the study is scheduled to last 5 years, i.e. an initial (prevalence) screening is followed by 4 annual (incidence) screenings.

In addition the following investigations are done: A prospective, longitudinal questionnaire assessment of enrolled participants who have received a false positive diagnosis. The questionnaire will focus on the consequences of receiving a false positive diagnosis. Answers from enrolled subjects who have received a false positive diagnosis will be compared to their own "baseline" responses, and responses from subjects who have received a negative result of their own low-dose CT scans All participants will annually be questioned regarding smoking habits, their motivation for cessation of smoking and will be advised to refrain from smoking to assess the effect of participation in a screening protocol for lung cancer on cessation of smoking.

Socioeconomic consequences of screening for lung cancer will be assessed by longitudinal registration of costs and benefits (e.g. morbidity, hospitalization, GP consultations etc.

Assess the value of PET scanning when screening for lung cancer.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Screening
• Condition: Lung Cancer
• Intervention: Procedure: annual CT screening
• Study Arms: Not Provided

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 5, 2007): 4104
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: January 2010
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00496977
• Other Study ID Numbers: KA-02045
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Danish Lung Cancer Group
• Original Study Sponsor: Same as current
• Collaborators: Ministry of the Interior and Health, Denmark

Investigators

• Principal Investigator: Jesper H Pedersen, MD, Dr.Sci; Gentofte University Hospital, Hellerup, Denmark

• PRS Account: Danish Lung Cancer Group
• Verification Date: June 2007