Danish Lung Cancer Screening Trial (DLCST)

Lung Cancer Clinical Trial

— DLCST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00496977
• Other study ID #: KA-02045
• Status: Active, not recruiting
• Phase: N/A
• First received: July 5, 2007
• Last updated: July 5, 2007
• Start date: October 2004
• Est. completion date: January 2010

Study information

• Verified date: June 2007
• Source: Danish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4104
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• annual CT screening

Locations

Country	Name	City	State
Denmark	Lung Screening Clinic, Gentofte University Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Danish Lung Cancer Group	Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer mortality		10 years
Secondary	lung cancer incidense and stagedistribution		5 years

External Links

•   home page of DLCST