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Danish Lung Cancer Screening Trial (DLCST) (DLCST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00496977
Recruitment Status : Unknown
Verified June 2007 by Danish Lung Cancer Group.
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Sponsor:
Collaborator:
Ministry of the Interior and Health, Denmark
Information provided by:
Danish Lung Cancer Group

Tracking Information
First Submitted Date  ICMJE July 5, 2007
First Posted Date  ICMJE July 6, 2007
Last Update Posted Date July 6, 2007
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
Lung cancer mortality [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
lung cancer incidense and stagedistribution [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Danish Lung Cancer Screening Trial (DLCST)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Screening
Condition  ICMJE Lung Cancer
Intervention  ICMJE Procedure: annual CT screening
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 5, 2007)
4104
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00496977
Other Study ID Numbers  ICMJE KA-02045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Danish Lung Cancer Group
Collaborators  ICMJE Ministry of the Interior and Health, Denmark
Investigators  ICMJE
Principal Investigator: Jesper H Pedersen, MD, Dr.Sci Gentofte University Hospital, Hellerup, Denmark
PRS Account Danish Lung Cancer Group
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP