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Lung CancerDLCSTNCT00496977

Danish Lung Cancer Screening Trial (DLCST)

A study testing annual CT screening in people with Lung Cancer, run by Danish Lung Cancer Group at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Lung Cancer
What is being tested?
annual CT screening
Type of treatment
Surgery or procedure
How many people
4,104 participants
Where
1 siteDenmark
Study dates
Oct 2004to Jan 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Lung Screening Clinic, Gentofte University Hospital

    Hellerup, DK-2900

Other trials in Denmark

About this study

Official title: Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.

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.

Read the 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.

Conditions
Lung Cancer
Being tested
annual CT screening
Keywords
lung cancer, CT scan, screening
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • annual CT screeningProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung cancer mortality

    Measured: 10 years

Secondary outcomes (1)

  1. lung cancer incidense and stagedistribution

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2007 (estimated)
  2. Study startOct 2004
  3. Study completionJan 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
4,104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496977
Sponsor's protocol ID
KA-02045
Acronym
DLCST
Status last verified
Jun 2007
First submitted
5 Jul 2007
Last updated
6 Jul 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37526548

  • 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.

    PubMed 32503869

  • 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.

    PubMed 32086352

  • 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.

    PubMed 31969362

  • 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.

    PubMed 26485620

  • 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.

    PubMed 25764091

  • 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.

    PubMed 25433982

  • 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.

    PubMed 24443174

  • 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.

    PubMed 24111638

  • 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.

    PubMed 23643591

  • 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.

    PubMed 22621716

  • 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.

    PubMed 20619924

Questions about this trial

What is this clinical trial studying?

A study testing annual CT screening in people with Lung Cancer, run by Danish Lung Cancer Group at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung cancer mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00496977, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2007.

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