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Danish Lung Cancer Screening Trial (DLCST)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00496977
Acronym
DLCST
Enrollment
4104
Registered
2007-07-06
Start date
2004-10-31
Completion date
2010-01-31
Last updated
2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, CT scan, screening

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.

Interventions

PROCEDUREannual CT screening

Sponsors

Ministry of the Interior and Health, Denmark
CollaboratorOTHER_GOV
Danish Lung Cancer Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Lung cancer mortality10 years

Secondary

MeasureTime frame
lung cancer incidense and stagedistribution5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026